CHMP Grants Positive Opinion for Pfizer/Merck KGaA Cancer Drug Plus Axitinib for Kidney Cancer
The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending marketing authorization for Bavencio (avelumab) in combination with axitinib for treating kidney cancer.
Pfizer and EMD Serono, the biopharmaceutical business of Merck KGaA, announced on Sept. 20, 2019 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Bavencio (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). The opinion was based on positive findings from a Phase III study, which demonstrated a significant extension in median progression-free survival (PFS) and a clinically meaningful improvement in objective response rate (ORR) for the combination across all prognostic risk groups compared with sunitinib.
The CHMP positive opinion will be reviewed by the European Commission, with a decision anticipated in the fourth quarter of 2019. EMD Serono and Pfizer have a global strategic alliance to jointly develop and commercialize Bavencio.
“Today’s positive CHMP opinion is a significant step toward potentially transforming the treatment landscape and bringing much needed options to people living with advanced renal cell carcinoma in Europe. We believe that the combination of [Bavencio] plus axitinib has the potential to help address a significant need for patients with advanced renal cell carcinoma for first-line treatments with a benefit across all prognostic risk groups, and we look forward to a decision from the European Commission,” said Luciano Rossetti, head of Global R&D for EMD Serono, in a company press release.
“Kidney cancer represents a significant burden in Europe, where incidence rates are among the highest in the world,” said Chris Boshoff, MD, PhD, chief development officer, Oncology, Pfizer Global Product Development, in the press release. “Pfizer has been a leader in the development of kidney cancer treatments for more than a decade, and it is a privilege to continue our efforts to bring a new treatment option to this community.”
FDA approved Bavencio in combination with axitinib for the first-line treatment of patients with advanced RCC in May 2019. A supplemental application for the combination treatment in unresectable or metastatic RCC was submitted in Japan in January 2019.
Source: Pfizer
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
