Pharmaceutical Technology

Daily Newsletter

31 October 2023

Daily Newsletter

EMA validates BMS’ Opdivo application for bladder cancer

If approved, the Opdivo/chemo combination would be the first of its kind to receive European authorisation for 1L urothelial cancer.

Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) got one step closer to getting another labeled indication under its belt as the European Medicines Agency (EMA) validated the application for its first-line use in combination with chemotherapy for unresectable or metastatic urothelial carcinoma.

The application is based on results from the Phase III CheckMate-901 trial (NCT03036098), which were presented at the European Society for Medical Oncology (ESMO) Congress 2023 that took place from 20-24 October in Madrid. The trial tested Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo as a standalone treatment. The treatment regimen showed statistically significant and clinically meaningful improvements in both overall survival (OS) and progression-free survival (PFS) when compared to standard-of-care cisplatin-based chemotherapy. The study is the first Phase III trial to show such improvements with an immunotherapy-based combination for this patient population, as per BMS.

Opdivo, a PD-1 inhibitor, was first approved by the US Food and Drug Administration (FDA) in 2014 for the treatment of metastatic melanoma. It has since been approved to treat various different types of cancer, including non-small cell lung cancer, esophageal squamous cell carcinoma (ESCC), kidney cancer and liver cancer. More recently, in October the FDA granted approval for Opdivo to treat stage IIB or IIC melanoma patients who have undergone complete resection.

Opdivo generated $8.2bn in sales last year, as per BMS’ Annual 2022 report. According to GlobalData, Opdivo is forecast to make $12.2bn in sales in 2029.

GlobalData is the parent company of Pharmaceutical Technology.

Analyzing the key M&A trends in the Contract Manufacturing industry

Despite challenging business conditions in 2021 and 2022, large CMOs were still involved in acquisitions to enhance their capabilities or scale of production. Catalent and Recipharm were particularly active in acquiring companies during this period, and these acquisitions had a focus on advanced biologic capabilities related to cell and gene therapies. CMOs are increasingly targeting companies with sophisticated (biologic and specialized) capabilities to manufacture modern drugs and seek high-value contracts.