Ipsen receives CHMP recommendation for Cabometyx in combination with Opdivo

pharmafile | March 1, 2021 | News story | Sales and Marketing Cancer, EMA, ipsen 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Ipsen’s 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 will now review the recommendation, and is expected to issue a final decision on the application in the coming months.

The CHMP’s positive opinion was based on results from the pivotal Phase III CheckMate -9ER trial, which demonstrated significant and clinically meaningful improvements in progression-free survival, overall survival, and objective response rate compared with sunitinib, with consistent efficacy benefits observed across key subgroups of patients. The combination of Cabometyx and Opdivo was well tolerated, and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line aRCC.

Additional data from the CheckMate -9ER trial were also presented at the recent American Society of Clinical Oncology 2021 Genitourinary Cancers Symposium, 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 compared with sunitinib.

The drug combination was approved by the FDA as first-line treatment for patients living with advanced renal cell carcinoma in January 2021. Ipsen and its partners have shared the data from the CheckMate -9ER trial with regulatory authorities around the world. 

Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen, said: “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.

“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.”

Dr Cristina Suárez, Medical Oncologist at the Vall d´Hebron University Hospital in Spain, and a lead investigator on the Phase III CheckMate -9ER trial, also commented: “Today’s news is welcomed by physicians treating people living with advanced renal cell carcinoma.

“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.”

Darcy Jimenez

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