FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
Genentech, a Roche Group member, announced FDA approval of Itovebi™ (inavolisib), in combination with palbociclib and fulvestrant, for treating PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer in adults. The approval is based on the Phase III INAVO120 study, which showed the Itovebi-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone (15.0 vs 7.3 months). This new treatment addresses an urgent unmet need for people with PIK3CA mutations, found in about 40% of HR-positive metastatic breast cancers. The regimen reduced the risk of disease worsening or death by 57%. Itovebi will be available in the U.S. in the coming weeks, marking Genentech's first targeted therapy for HR-positive breast cancer, the most prevalent subtype.
Genentech, un membro del gruppo Roche, ha annunciato l'approvazione da parte della FDA di Itovebi™ (inavolisib), in combinazione con palbociclib e fulvestrant, per il trattamento del cancro al seno avanzato con mutazione PIK3CA, positivo per HR e negativo per HER2 negli adulti. L'approvazione si basa sullo studio di Fase III INAVO120, che ha dimostrato che il regime basato su Itovebi più che raddoppia la sopravvivenza libera da progressione rispetto al solo palbociclib e fulvestrant (15,0 contro 7,3 mesi). Questo nuovo trattamento risponde a un urgente bisogno non soddisfatto per le persone con mutazioni PIK3CA, presenti in circa il 40% dei tumori al seno metastatici positivi per HR. Il regime ha ridotto il rischio di peggioramento della malattia o di morte del 57%. Itovebi sarà disponibile negli Stati Uniti nelle prossime settimane, segnando la prima terapia mirata di Genentech per il cancro al seno positivo per HR, il sottotipo più prevalente.
Genentech, un miembro del grupo Roche, anunció la aprobación por parte de la FDA de Itovebi™ (inavolisib), en combinación con palbociclib y fulvestrant, para el tratamiento del cáncer de mama avanzado con mutación PIK3CA, positivo para HR y negativo para HER2 en adultos. La aprobación se basa en el estudio de Fase III INAVO120, que mostró que el régimen basado en Itovebi más que duplica la supervivencia libre de progresión en comparación con palbociclib y fulvestrant solos (15,0 contra 7,3 meses). Este nuevo tratamiento aborda una necesidad urgente no satisfecha para las personas con mutaciones PIK3CA, presentes en aproximadamente el 40% de los cánceres de mama metastásicos positivos para HR. El régimen redujo el riesgo de empeoramiento de la enfermedad o muerte en un 57%. Itovebi estará disponible en EE. UU. en las próximas semanas, marcando la primera terapia dirigida de Genentech para el cáncer de mama positivo para HR, el subtipo más prevalente.
Genentech, 로슈 그룹의 일원,는 Itovebi™ (inavolisib)의 FDA 승인을 발표했습니다. 이 약물은 팔보시클립과 풀베스트란트와 함께 PIK3CA 변이, HR 양성, HER2 음성의 진행성 유방암 치료에 사용됩니다. 이 승인은 3상 INAVO120 연구를 기반으로 하며, 이 연구는 Itovebi 기반 요법이 팔보시클립과 풀베스트란트 단독요법에 비해 진행 없는 생존 기간을 두 배 이상 늘린 것으로 나타났습니다 (15.0 대 7.3개월). 이 새로운 치료법은 PIK3CA 변이를 가진 사람들을 위한 시급한 미충족 수요를 해결합니다. 이러한 변이는 HR 양성 전이성 유방암의 약 40%에서 발견됩니다. 이 요법은 질병 악화 또는 사망의 위험을 57% 줄였습니다. Itovebi는 향후 몇 주 내에 미국에서 제공될 예정이며, 이는 Genentech의 HR 양성 유방암에 대한 첫 번째 표적 치료제로 자리 잡게 됩니다, 이는 가장 흔한 아형입니다.
Genentech, membre du groupe Roche, a annoncé l'approbation par la FDA de Itovebi™ (inavolisib), en combinaison avec palbociclib et fulvestrant, pour traiter le cancer du sein avancé avec mutation PIK3CA, positif pour HR et négatif pour HER2 chez les adultes. L'approbation est basée sur l'étude de Phase III INAVO120, qui a montré que le régime basé sur Itovebi doublait plus que la survie sans progression par rapport au palbociclib et au fulvestrant seuls (15,0 contre 7,3 mois). Ce nouveau traitement répond à un besoin urgent non satisfait pour les personnes ayant des mutations PIK3CA, présentes dans environ 40 % des cancers du sein métastatiques positifs pour HR. Le régime a réduit le risque d'aggravation de la maladie ou de décès de 57 %. Itovebi sera disponible aux États-Unis dans les semaines à venir, marquant la première thérapie ciblée de Genentech pour le cancer du sein positif pour HR, le sous-type le plus répandu.
Genentech, ein Mitglied der Roche-Gruppe, hat die FDA-Zulassung für Itovebi™ (inavolisib) in Kombination mit Palbociclib und Fulvestrant zur Behandlung von PIK3CA-mutiertem, HR-positivem, HER2-negativem fortgeschrittenem Brustkrebs bei Erwachsenen bekannt gegeben. Die Zulassung basiert auf der Phase-III-Studie INAVO120, die zeigte, dass das auf Itovebi basierende Regime die progressionsfreie Überlebenszeit mehr als verdoppelte im Vergleich zu Palbociclib und Fulvestrant allein (15,0 vs. 7,3 Monate). Diese neue Behandlung deckt einen dringenden ungedeckten Bedarf für Menschen mit PIK3CA-Mutationen, die bei etwa 40% der HR-positiven metastatischen Brustkrebse vorkommen, ab. Das Regime reduzierte das Risiko einer Verschlechterung der Erkrankung oder des Todes um 57%. Itovebi wird in den kommenden Wochen in den USA erhältlich sein und markiert die erste zielgerichtete Therapie von Genentech für HR-positiven Brustkrebs, den am weitesten verbreiteten Subtyp.
- Itovebi-based regimen more than doubled progression-free survival (15.0 vs 7.3 months)
- Reduced risk of disease worsening or death by 57%
- Addresses unmet need for PIK3CA-mutated breast cancer (40% of HR-positive metastatic cases)
- Granted FDA Priority Review and Breakthrough Therapy Designation
- Positive trend observed in overall survival data
- Overall survival data were immature at the time of primary analysis
– Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting –
– This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis –
– Itovebi is Genentech’s first targeted therapy approved for people with HR-positive disease, the most prevalent breast cancer subtype, marking an important step in our ambition to continue bringing innovative medicines to more people with breast cancer –
“The PI3K pathway plays a pivotal role in disease progression and has been challenging to target,” said Komal Jhaveri, M.D., section head for the endocrine therapy research portfolio and clinical director of the early drug development service at Memorial Sloan Kettering Cancer Center, and one of the principal investigators of the INAVO120 study. “The Itovebi-based regimen more than doubled progression-free survival and maintained a manageable safety and tolerability profile, adding a new standard in how PIK3CA-mutated breast cancers are treated.”
“With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes today’s approval all the more significant.”
This approval is based on results of the pivotal Phase III INAVO120 study, which showed that the Itovebi-based regimen reduced the risk of disease worsening or death by
“We are thrilled by the approval of the Itovebi-based regimen, which is a huge step forward for advanced breast cancer patients with a PIK3CA mutation,” said Jean Sachs, CEO of Living Beyond Breast Cancer. “It remains critical that all patients have access to early, comprehensive biomarker testing so they can better understand what treatment options may be most beneficial for them and their tumor type.”
The Itovebi-based regimen was granted FDA Priority Review and Breakthrough Therapy Designation in May 2024 based on the INAVO120 study results. Data from INAVO120 are also being used for filing submissions to other global health authorities, including the European Medicines Agency. Itovebi will be available in the
Itovebi is currently being investigated in various combinations across three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer. We continue to evaluate opportunities to expand our clinical development program to address patient unmet needs in various tumor types across oncology.
About the INAVO120 study
The INAVO120 study [NCT04191499] is a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.
Beyond INAVO120, Itovebi is currently being investigated in two additional company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:
- in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy (INAVO121; NCT05646862), and
- combination with dual HER2 blockade versus dual HER2 blockade and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239).
About Hormone Receptor (HR)-Positive Breast Cancer
HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately
What is Itovebi?
Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.
Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.
It is not known if Itovebi is safe and effective in children.
Important Safety Information
What are the possible side effects of Itovebi?
Itovebi may cause serious side effects, including:
-
High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
- difficulty breathing
- blurred vision
- nausea and vomiting (lasting more than 2 hours)
- unusually increased appetite
- stomach pain
- weight loss
- excessive thirst
- fruity-smelling breath
- dry mouth
- flushed face and dry skin
- more frequent urination than usual or a higher amount of urine than normal
- feeling unusually sleepy or tired
- confusion
-
Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
- pain
- swelling
- redness
- ulcers
- Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal pain), or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea.
Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.
The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:
- decreased white blood cell counts, red blood cell counts, and platelet counts
- decreased blood levels of calcium, potassium, sodium, and magnesium
- increased creatinine blood levels
- tiredness
- increased blood levels of the liver enzyme alanine transaminase (ALT)
- nausea
- rash
- loss of appetite
- COVID-19 infection
- headache
Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (877) 436-3683.
Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of diabetes or high blood sugar
- have kidney problems
- are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
- You should use effective non-hormonal birth control (contraception) during treatment and for 1 week after your last dose of Itovebi. Talk to your healthcare provider about what birth control method is right for you during this time.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.
Males with female partners who are able to become pregnant:
- You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.
- are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit https://www.itovebi.com.
About Genentech in Breast Cancer
Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in HER2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including estrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in
Dr. Jhaveri has financial interests related to Roche and Genentech.
All trademarks used or mentioned in this release are protected by law.
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Source: Genentech
FAQ
What is Itovebi and what has the FDA approved it for?
How effective was Itovebi in the INAVO120 study for RHHBY?
What percentage of HR-positive metastatic breast cancers have the PIK3CA mutation that Itovebi targets?
When will Itovebi be available in the U.S. market for RHHBY?
What designations did the FDA grant to Itovebi before its approval for RHHBY?
