Ipsen receives positive CHMP opinion recommending Cabometyx® in combination with Opdivo® as first-line treatment for patients living with advanced renal cell carcinoma
PARIS, FRANCE -- Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Cabometyx® (cabozantinib) in combination with Bristol Myers Squibb’s Opdivo® (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). The European Commission, which has the authority to approve medicines for the European Union (E.U.), will now review the CHMP recommendation and a final decision on the application in the E.U. is expected in the coming months.
“Advanced renal cell carcinoma is a disease that significantly impacts the lives of people around the world. We’re proud to be able to share that the CHMP has confirmed a positive recommendation for Cabometyx® in combination with Opdivo®, bringing this impactful new treatment option one step closer for patients,” said Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen. “At Ipsen, we are committed to progressing treatment for cancers which have an urgent need for additional therapeutic options and this recommendation marks an important milestone in achieving this.”
The CHMP adopted the positive opinion based on results from the pivotal Phase III CheckMate -9ER trial, which demonstrated significant and clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared to sunitinib, with consistent efficacy benefits observed across key subgroups of patients.1 Cabometyx® combined with Opdivo® was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor (TKI) components in first-line advanced RCC.1 The full data from the CheckMate -9ER trial were presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. At the recent American Society of Clinical Oncology 2021 Genitourinary Cancers Symposium (ASCO GU), additional data from the CheckMate -9ER trial were also presented, highlighting sustained superior efficacy with a longer duration of follow-up as well as significantly improved health-related quality of life outcomes for the combination versus sunitinib.2,3
Ipsen and its partners have shared the CheckMate -9ER data with regulatory authorities around the world. The combination of Cabometyx® and Opdivo® was approved by the U.S. Food and Drug Administration (FDA) as first-line treatment for patients living with advanced renal cell carcinoma in January 2021.
“Today’s news is welcomed by physicians treating people living with advanced renal cell carcinoma,” said Dr. Cristina Suárez, Medical Oncologist at the Vall d´Hebron University Hospital, Barcelona, Spain, and a lead investigator on the Phase III CheckMate -9ER trial. “The positive CHMP opinion brings us one step closer to the promise of a new approach that combines improved treatment outcomes, a favorable tolerability profile and superior health-related quality of life for patients.”