Rigel Pharmaceuticals Issues Dear Healthcare Provider Letter for GAVRETO® (pralsetinib)
Rigel Pharmaceuticals (RIGL) announced the issuance of a Dear Health Care Provider (DHCP) letter regarding a new safety signal for GAVRETO® (pralsetinib), following FDA consultation. GAVRETO is approved for treating adult patients with metastatic RET fusion-positive non-small cell lung cancer and certain thyroid cancer patients. The letter has been posted to the GAVRETO Healthcare Provider website. The company emphasizes patient safety as its highest priority and encourages healthcare providers and patients to report adverse events to Rigel's Medical Communications Center or directly to the FDA.
Rigel Pharmaceuticals (RIGL) ha annunciato l'emissione di una lettera ai fornitori di assistenza sanitaria (DHCP) riguardante un nuovo segnale di sicurezza per GAVRETO® (pralsetinib), a seguito di consultazione con la FDA. GAVRETO è approvato per il trattamento di pazienti adulti con carcinoma polmonare non a piccole cellule metastatico positivo per fusione RET e per alcuni pazienti con cancro tiroideo. La lettera è stata pubblicata sul sito web dei fornitori di assistenza sanitaria di GAVRETO. L'azienda sottolinea che la sicurezza dei pazienti è la sua massima priorità e incoraggia i fornitori di assistenza sanitaria e i pazienti a segnalare eventi avversi al Centro di Comunicazione Medica di Rigel o direttamente alla FDA.
Rigel Pharmaceuticals (RIGL) anunció la emisión de una carta a los proveedores de atención médica (DHCP) sobre una nueva señal de seguridad para GAVRETO® (pralsetinib), tras una consulta con la FDA. GAVRETO está aprobado para el tratamiento de pacientes adultos con cáncer de pulmón no microcítico metastásico positivo por fusión RET y ciertos pacientes con cáncer de tiroides. La carta ha sido publicada en el sitio web de proveedores de atención médica de GAVRETO. La empresa enfatiza que la seguridad del paciente es su máxima prioridad y alienta a los proveedores de atención médica y a los pacientes a reportar eventos adversos al Centro de Comunicaciones Médicas de Rigel o directamente a la FDA.
리겔 제약(RIGL)은 FDA와의 상담 후 GAVRETO®(프랄세티닙)에 대한 새로운 안전 신호에 관한 건강 관리 제공자에게 보낸 편지(DHCP)를 발행했다고 발표했습니다. GAVRETO는 전이성 RET 융합 양성 비소세포 폐암 및 특정 갑상선암 환자의 치료를 위해 승인되었습니다. 이 편지는 GAVRETO의 건강 관리 제공자 웹사이트에 게시되었습니다. 회사는 환자 안전을 최우선으로 강조하며, 의료 제공자와 환자에게 리겔의 의료 커뮤니케이션 센터나 FDA에 직접 부작용을 보고할 것을 권장합니다.
Rigel Pharmaceuticals (RIGL) a annoncé l'émission d'une lettre aux fournisseurs de soins de santé (DHCP) concernant un nouveau signal de sécurité pour GAVRETO® (pralsetinib), suite à une consultation avec la FDA. GAVRETO est approuvé pour le traitement des patients adultes atteints de cancer du poumon non à petites cellules métastatique positif pour la fusion RET et de certains patients atteints de cancer de la thyroïde. La lettre a été publiée sur le site web des fournisseurs de soins de santé de GAVRETO. L'entreprise souligne que la sécurité des patients est sa priorité absolue et encourage les prestataires de soins de santé et les patients à signaler les événements indésirables au Centre de Communications Médicales de Rigel ou directement à la FDA.
Rigel Pharmaceuticals (RIGL) gab die Ausstellung eines Schreibens an die Gesundheitsdienstleister (DHCP) bekannt, das ein neues Sicherheitssignal für GAVRETO® (Pralsetinib) betrifft, nach Rücksprache mit der FDA. GAVRETO ist zur Behandlung von Erwachsenen mit metastasierendem RET-Fusions-positiven nicht-kleinzelligem Lungenkrebs und bestimmten Schilddrüsenkrebspatienten zugelassen. Das Schreiben wurde auf der GAVRETO-Website für Gesundheitsdienstleister veröffentlicht. Das Unternehmen betont, dass die Sicherheit der Patienten oberste Priorität hat und ermutigt Gesundheitsdienstleister und Patienten, unerwünschte Ereignisse an das Medizinische Kommunikationszentrum von Rigel oder direkt an die FDA zu melden.
- None.
- New safety signal identified for GAVRETO requiring DHCP letter issuance
- Serious adverse events reported including ILD/pneumonitis with 0.2% fatal reactions
- 35% of patients experienced hypertension, with 18% Grade 3
- Serious hepatic adverse reactions occurred in 1.5% of patients
Insights
The DHCP letter for GAVRETO signals heightened regulatory scrutiny and potential market impact. The safety signal update for this RET fusion-positive cancer treatment could affect prescription patterns and market adoption. The drug treats two significant indications - metastatic NSCLC and advanced thyroid cancer, representing substantial market opportunities.
The reported adverse events are significant, including ILD/pneumonitis in 12% of patients, with some fatal cases and hypertension in 35% of patients. These safety concerns could lead to more cautious prescribing patterns and increased monitoring requirements, potentially impacting revenue growth. However, the maintained FDA approval suggests the risk-benefit profile remains favorable for indicated patient populations.
This safety update carries notable liability implications. The formal DHCP letter issuance, in consultation with the FDA, demonstrates proactive risk management but also acknowledges serious safety concerns. The timing is particularly significant as Rigel recently acquired the NDA from Blueprint Medicines in June 2024.
The detailed adverse event reporting mechanisms and comprehensive safety information disclosure help mitigate legal exposure. However, the documented severe adverse events, including fatal cases, could potentially lead to increased pharmacovigilance requirements and liability risks. The accelerated approval status for thyroid cancer indication adds another layer of regulatory complexity.
Patient safety is Rigel's highest priority. We are committed to ensuring healthcare providers are aware of this update.
Healthcare providers and patients are encouraged to report adverse events in patients taking GAVRETO to the Rigel Medical Communications Center at 1-800-983-1329 or producthelp@rigel.com. You may also report adverse events associated with taking GAVRETO directly to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).
Rigel announced the completion of the transfer to Rigel of the New Drug Application (NDA) for GAVRETO from Blueprint Medicines Corporation in June 2024.
About GAVRETO® (pralsetinib)
INDICATIONS
GAVRETO (pralsetinib) is indicated for the treatment of:
- Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test
- Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)*
*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 trial(s).
IMPORTANT SAFETY INFORMATION
- Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in
12% of patients who received GAVRETO, including3.3% with Grade 3-4, and0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD. - Hypertension: Occurred in
35% of patients, including Grade 3 hypertension in18% of patients. Overall,8% had their dose interrupted and4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity. - Hepatotoxicity: Serious hepatic adverse reactions occurred in
1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in49% of patients, including Grade 3 or 4 in7% and increased alanine aminotransferase (ALT) occurred in37% of patients, including Grade 3 or 4 in4.8% . The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity. - Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in
4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage. - Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.
- Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.
- Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.
- Common adverse reactions (≥
25% ) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2% ) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin. - Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.
- Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.
- Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here to see the full Prescribing Information and Patient Information for GAVRETO.
GAVRETO is a registered trademark of Rigel Pharmaceuticals, Inc.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in
Forward Looking Statements
This press release contains forward-looking statements relating to, among other things, safety signal and warnings and precautions regarding the use of GAVRETO (pralsetinib) and has direct reference to a dear doctor letter which further discusses ad hoc analysis from the AcceleRET-Lung trial and corresponding updates to the product label. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "forthcoming," "potential", "may", "expects", "will" and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of GAVRETO; risks that the FDA or other regulatory authorities may make adverse decisions regarding GAVRETO; risks that GAVRETO may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop market and distribute GAVRETO; risks related to the transition of GAVRETO to Rigel, including risks related to the effectiveness of transition services and drug continuity; market competition for GAVRETO; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.
Contact for Investors & Media:
Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com
Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com
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SOURCE Rigel Pharmaceuticals, Inc.
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