Opdivo: Bristol-Myers Squibb’s Oncology Blockbuster Drug in 4Q17
Bristol-Myers Squibb’s (BMY) Opdivo is approved for the treatment of non-small cell lung cancer, classical Hodgkin’s lymphoma, renal cell carcinoma, and metastatic melanoma. It’s also approved for the treatment of squamous cell carcinoma of head and neck, urothelial carcinoma, hepatocellular carcinoma, and dMMR/MSI-H colorectal cancer.
The chart below shows the revenue trend for Opdivo since 1Q16. For 4Q17, Opdivo reported revenues of ~$1.4 billion for 4.0% growth compared to revenues of ~$1.3 billion during 4Q16.
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Recent Opdivo developments
On February 5, 2018, Bristol-Myers Squibb announced that Checkmate-227 met its co-primary endpoint of progression-free survival. Checkmate-227 is a Phase 3 study evaluating Opdivo plus Yervoy combination as a first-line treatment for non-small cell lung cancer
On December 20, 2017, the FDA approved Opdivo injection for the treatment of melanoma with lymph nodes or metastatic disease where patients have undergone complete resection.
On December 20, 2017, Bristol-Myers Squibb and Taris Biomedical LLC entered into a collaboration for evaluating the safety, preliminary efficacy, and tolerability of Taris’s investigational drug TAR-200 in combination with Opdivo. This drug is for the treatment of patients with muscle-invasive bladder cancer.
On December 13, 2017, the FDA granted priority review to Opdivo plus Yervoy combination for use in the treatment of intermediate- and poor-risk patients with advanced renal cell carcinoma. The action date for the supplemental Biologics License Application is April 16, 2018.
On December 5, 2017, FDA lifted the partial clinical holds on two of the clinical studies evaluating Opdivo in combination with other drugs for the treatment of patients with refractory or relapsed multiple myeloma. The two clinical studies are Checkmate-039 and CA204142.
Opdivo is approved for the treatment of non-small cell lung cancer (or NSCLC). Other drugs for the treatment of NSCLC include Pfizer’s (PFE) Xalkori, Merck & Co.’s (MRK) Keytruda, and AstraZeneca’s (AZN) Tagrisso.