Bristol Myers Opdivo for skin cancer gets review in US, EU
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- The U.S. Food and Drug Administration (FDA) accepted to review Bristol Myers Squibb's (NYSE:BMY) supplemental biologics license application (sBLA) seeking approval of Opdivo (nivolumab) as monotherapy in the adjuvant setting to treat patients with completely resected stage 2B or 2C melanoma.
- The FDA is expected to make a decision on the sBLA by Oct. 13.
- In addition, Bristol Myers said that European Medicines Agency (EMA) validated the Type II variation marketing authorization application (MAA) for Opdivo for the same use.
- The filings are backed by data from a from a phase 3 study called CheckMate -76K, which showed that Opdivo showed a statistically significant and clinically meaningful benefit in recurrence-free survival, according to the company.
- Melanoma is a type of skin cancer.
- Blockbuster cancer immunotherapy Opdivo had generated revenue of ~$2.22B in Q4, growing +11% Y/Y.
- BMY +0.17% to $70.11 premarket Feb. 28