Bristol Myers Squibb Receives Positive CHMP Opinion for Perioperative Regimen of Neoadjuvant Opdivo® (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo for Resectable Non-Small Cell Lung Cancer in Patients with Tumor Cell PD-L1...
Bristol Myers Squibb (NYSE: BMY) received a positive CHMP opinion recommending approval of Opdivo® (nivolumab) for resectable non-small cell lung cancer (NSCLC) treatment in the EU. The recommendation is for a perioperative regimen combining neoadjuvant Opdivo with chemotherapy, followed by surgery and adjuvant Opdivo monotherapy in adult patients with tumor PD-L1 expression ≥1%.
The recommendation is based on the Phase 3 CheckMate -77T trial, which demonstrated significant improvement in event-free survival and clinically meaningful improvements in pathologic complete response and major pathologic response. The safety profile aligned with previous NSCLC studies.
This marks BMY's second Opdivo-based regimen for resectable NSCLC in the EU. The treatment received FDA approval in October 2024 for similar indications in the US. The European Commission will review the recommendation, with a final decision expected within two months.
Bristol Myers Squibb (NYSE: BMY) ha ricevuto un parere positivo dal CHMP che raccomanda l'approvazione di Opdivo® (nivolumab) per il trattamento del cancro polmonare non a piccole cellule (NSCLC) resecabile nell'UE. La raccomandazione riguarda un regime perioperatorio che combina Opdivo neoadiuvante con chemioterapia, seguito da chirurgia e monoterapia con Opdivo adiuvante in pazienti adulti con espressione del PD-L1 del tumore ≥1%.
La raccomandazione si basa sul trial di Fase 3 CheckMate -77T, che ha dimostrato un significativo miglioramento della sopravvivenza libera da eventi e miglioramenti clinicamente significativi nella risposta patologica completa e nella risposta patologica maggiore. Il profilo di sicurezza è stato in linea con studi precedenti sul NSCLC.
Questo segna il secondo regime basato su Opdivo per NSCLC resecabile nell'UE da parte di BMY. Il trattamento ha ricevuto l'approvazione della FDA nell'ottobre 2024 per indicazioni simili negli Stati Uniti. La Commissione Europea esaminerà la raccomandazione, con una decisione finale attesa entro due mesi.
Bristol Myers Squibb (NYSE: BMY) recibió una opinión positiva del CHMP recomendando la aprobación de Opdivo® (nivolumab) para el tratamiento del cáncer de pulmón no microcítico (NSCLC) resecable en la UE. La recomendación es para un régimen perioperatorio que combina Opdivo neoadyuvante con quimioterapia, seguido de cirugía y monoterapia con Opdivo adyuvante en pacientes adultos con expresión del PD-L1 del tumor ≥1%.
La recomendación se basa en el ensayo de Fase 3 CheckMate -77T, que demostró una mejora significativa en la supervivencia libre de eventos y mejoras clínicamente significativas en la respuesta patológica completa y la respuesta patológica mayor. El perfil de seguridad fue consistente con estudios previos de NSCLC.
Esto marca el segundo régimen basado en Opdivo para NSCLC resecable en la UE por parte de BMY. El tratamiento recibió la aprobación de la FDA en octubre de 2024 para indicaciones similares en los EE. UU. La Comisión Europea revisará la recomendación, con una decisión final esperada en un plazo de dos meses.
브리스톨 마이어스 스퀴브 (NYSE: BMY)는 옵디보® (니볼루맙)의 유럽연합 내 절제 가능한 비소세포 폐암(NSCLC) 치료에 대한 승인을 권장하는 긍정적인 CHMP 의견을 받았습니다. 이 권장 사항은 네오아쥬번트 옵디보와 화학요법을 결합한 수술 전 치료 요법을 포함하며, 이후 수술과 성인 환자에서 PD-L1 발현이 ≥1%인 경우 옵디보 단독 요법이 이어집니다.
이 권장 사항은 3상 CheckMate -77T 시험을 기반으로 하며, 사건 없는 생존율의 유의미한 개선과 병리학적 완전 반응 및 주요 병리학적 반응에서 임상적으로 의미 있는 개선을 입증했습니다. 안전성 프로필은 이전 NSCLC 연구와 일치했습니다.
이는 BMY의 EU 내 절제 가능한 NSCLC에 대한 두 번째 옵디보 기반 요법을 의미합니다. 이 치료법은 2024년 10월 미국에서 유사한 적응증에 대해 FDA 승인을 받았습니다. 유럽연합 집행위원회는 이 권장 사항을 검토할 예정이며, 최종 결정은 두 달 이내에 예상됩니다.
Bristol Myers Squibb (NYSE: BMY) a reçu un avis positif du CHMP recommandant l'approbation de Opdivo® (nivolumab) pour le traitement du cancer du poumon non à petites cellules (NSCLC) résécable dans l'UE. La recommandation concerne un régime périopératoire combinant Opdivo néo-adjuvant avec une chimiothérapie, suivi d'une chirurgie et d'une monothérapie adjuvante avec Opdivo chez les patients adultes ayant une expression de PD-L1 tumorale ≥1%.
Cette recommandation est basée sur l', qui a montré une amélioration significative de la survie sans événement et des améliorations cliniquement significatives dans la réponse pathologique complète et la réponse pathologique majeure. Le profil de sécurité était en accord avec les études précédentes sur le NSCLC.
Ceci marque le deuxième régime basé sur Opdivo pour le NSCLC résécable de BMY dans l'UE. Le traitement a reçu l'approbation de la FDA en octobre 2024 pour des indications similaires aux États-Unis. La Commission européenne examinera la recommandation, avec une décision finale attendue dans les deux mois.
Bristol Myers Squibb (NYSE: BMY) erhielt eine positive CHMP-Empfehlung zur Genehmigung von Opdivo® (Nivolumab) zur Behandlung von resektablem nicht-kleinzelligem Lungenkrebs (NSCLC) in der EU. Die Empfehlung betrifft ein perioperatives Regime, das neoadjuvantes Opdivo mit Chemotherapie kombiniert, gefolgt von einer Operation und adjuvanter Opdivo-Monotherapie bei erwachsenen Patienten mit einer Tumor-PD-L1-Expression von ≥1%.
Die Empfehlung basiert auf der Phase-3-Studie CheckMate -77T, die eine signifikante Verbesserung des ereignisfreien Überlebens und klinisch bedeutsame Verbesserungen in der pathologischen Komplettantwort und der major pathologischen Antwort zeigte. Das Sicherheitsprofil stimmte mit früheren NSCLC-Studien überein.
Dies markiert das zweite auf Opdivo basierende Regime von BMY für resektables NSCLC in der EU. Die Behandlung erhielt im Oktober 2024 die FDA-Zulassung für ähnliche Indikationen in den USA. Die Europäische Kommission wird die Empfehlung prüfen, eine endgültige Entscheidung wird innerhalb von zwei Monaten erwartet.
- Received positive CHMP recommendation for Opdivo in resectable NSCLC
- Phase 3 trial demonstrated significant improvement in event-free survival
- Second Opdivo-based regimen for NSCLC treatment in EU
- Already received FDA approval in October 2024
- Overall survival data from CheckMate -77T trial still pending
Insights
The CHMP recommendation for BMY's perioperative Opdivo regimen represents a significant advancement in resectable NSCLC treatment. The CheckMate -77T trial demonstrated statistically significant improvements in event-free survival along with meaningful improvements in pathologic complete response and major pathologic response - critical endpoints that correlate with long-term outcomes.
This perioperative approach (neoadjuvant Opdivo+chemotherapy followed by surgery and adjuvant Opdivo) addresses a critical unmet need in early-stage NSCLC, where 30-55% of patients experience recurrence despite surgical resection. The PD-L1 ≥1% biomarker requirement appropriately targets patients most likely to benefit from immunotherapy.
It's particularly notable that this represents BMY's second Opdivo-based regimen for resectable NSCLC, establishing the company's leadership in treating lung cancer across the disease continuum. The treatment's consistency with previously established safety profiles suggests manageable toxicity, a crucial consideration for therapies used in potentially curative settings.
With FDA approval already secured in October 2024 and now the positive CHMP opinion, this regimen is positioned to become a new standard of care for eligible NSCLC patients throughout major global markets, potentially improving cure rates in this deadly disease.
This CHMP recommendation strengthens BMY's oncology franchise, particularly in the strategically important lung cancer segment. Opdivo, a cornerstone product for BMY with approvals in over 65 countries, continues expanding its utility across multiple cancer types and treatment settings - now with proven efficacy in both neoadjuvant and perioperative NSCLC applications.
The perioperative indication targets the estimated 60% of NSCLC cases that are non-metastatic, a substantial patient population that represents significant commercial opportunity. By targeting earlier-stage disease, BMY expands its addressable market while positioning Opdivo earlier in treatment paradigms, potentially extending duration of therapy.
This reinforces BMY's immuno-oncology leadership following the October 2024 FDA approval for a similar indication. The company's dual approach of developing Opdivo in both monotherapy and combination settings across multiple tumor types has created a remarkably versatile product portfolio.
The expansion into earlier disease settings is particularly important as competition intensifies in the PD-1/PD-L1 inhibitor class for metastatic indications. By securing approvals in adjuvant/neoadjuvant settings where fewer competitors have established presence, BMY creates differentiation for Opdivo. With European Commission approval typically following CHMP recommendations, BMY is poised to capture additional market share in one of oncology's largest therapeutic categories.
Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo
If approved by the European Commission, the perioperative regimen would be the company’s second Opdivo-based regimen available for the treatment of resectable non-small cell lung cancer in the European Union
Bristol Myers Squibb Receives Positive CHMP Opinion for Perioperative Regimen of Neoadjuvant Opdivo® (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo for Resectable Non-Small Cell Lung Cancer in Patients with Tumor Cell PD-L1 Expression ≥
Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab), in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥
“Preventing disease recurrence and improving long-term outcomes for patients with NSCLC earlier in the treatment journey is critical to addressing unmet needs and is one of our top priorities,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “With today's positive opinion from the CHMP, we are pleased that our second Opdivo-based regimen for certain patients with resectable NSCLC whose tumors have PD-L1 expression ≥
The CheckMate -77T trial also demonstrated clinically meaningful improvements in the secondary efficacy endpoints of pathologic complete response (pCR) and major pathologic response (MPR). The safety profile of the perioperative regimen was consistent with previously reported studies in NSCLC. The EFS, pCR and MPR results from the CheckMate -77T trial were first presented at the European Society of Medical Oncology (ESMO) Congress 2023 and published in The New England Journal of Medicine. CheckMate -77T is ongoing to assess another key secondary endpoint of overall survival (OS).
In October 2024, the CheckMate -77T trial was used as the basis for the
CheckMate -77T represents the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable non-metastatic NSCLC. Opdivo is the only immunotherapy treatment with Phase 3 data in both the neoadjuvant only and perioperative NSCLC treatment setting. In addition, Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
In the EU, the EC delivers its final decision within approximately two months following receipt of the CHMP opinion. Once issued, the decision will be applicable to all EU member states as well as in the European Economic Area (EEA) countries
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -77T clinical trial.
About CheckMate -77T
CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant placebo plus chemotherapy followed by surgery and adjuvant placebo in 461 patients with resectable stage IIA to IIIB NSCLC. The primary endpoint of the trial is EFS. Secondary endpoints include OS, pathologic complete response and major pathologic response.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant treatment after surgery.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
IMPORTANT SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.
Immune-Mediated Pneumonitis
OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in
In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in
Immune-Mediated Colitis
OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in
Immune-Mediated Hepatitis and Hepatotoxicity
OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in
OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in
Immune-Mediated Endocrinopathies
OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.
In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in
In patients receiving OPDIVO monotherapy, hypophysitis occurred in
In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in
In patients receiving OPDIVO monotherapy, thyroiditis occurred in
In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in
In patients receiving OPDIVO monotherapy, hypothyroidism occurred in
In patients receiving OPDIVO monotherapy, diabetes occurred in
Immune-Mediated Nephritis with Renal Dysfunction
OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in
Immune-Mediated Dermatologic Adverse Reactions
OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.
YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in
Other Immune-Mediated Adverse Reactions
The following clinically significant immune-mediated adverse reactions occurred at an incidence of <
In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <
Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.
Infusion-Related Reactions
OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in
Complications of Allogeneic Hematopoietic Stem Cell Transplantation
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.
Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.
Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone
In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
Lactation
There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥
Surgery Related Adverse Reactions
In Checkmate 77T,
Please see
Clinical Trials and Patient Populations
Checkmate 227-previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 649–previously untreated advanced or metastatic gastric cancer, gastroesophageal junction and esophageal adenocarcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 238–adjuvant treatment of patients with completely resected Stage III or Stage IV melanoma; Checkmate 76K–adjuvant treatment of patients 12 years of age and older with completely resected Stage IIB or Stage IIC melanoma; Checkmate 274–adjuvant treatment of urothelial carcinoma; Checkmate 275–previously treated advanced or metastatic urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Attraction-3–esophageal squamous cell carcinoma; Checkmate 648-previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma in combination with chemotherapy; Checkmate 648-previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma combination with YERVOY; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 816–neoadjuvant non-small cell lung cancer, in combination with platinum-doublet chemotherapy; Checkmate 77T–Neoadjuvant treatment with platinum-doublet chemotherapy for non-small cell lung cancer followed by single-agent OPDIVO as adjuvant treatment after surgery; Checkmate 901–Adult patients with unresectable or metastatic urothelial carcinoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 205/039–classical Hodgkin lymphoma
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the CHMP opinion is not binding on the EC, that Opdivo® (nivolumab) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether Opdivo for such indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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