Bristol-Myers' Opdivo notches two key regulatory victories in US, UK
- Bristol-Myers Sqibb's melanoma drug Opdivo notched two regulatory wins over the past week. The FDA on Saturday approved Opdivo for treatment of BRAF V600 wild-type and BRAF V600 mutation-positive metastatic melanoma in combination with the drug Yervoy.
- In November, the FDA had declined to grant approval to Opdivo as a single agent for this indication and asked for more data in its complete response letter.
- Additionally, the U.K.'s health-costs regulator, the National Institute for Health and Care Excellence, last week endorsed the drug for use in treating skin cancer. A month prior, it had rejected the drug for treatment of lung cancer due to cost.
Bristol-Myers won the expanded approval from the FDA based on the progression free survival (PFS) rates in a phase 3 study. Median PFS for the combination treatment of Opdivo and Yervoy was 11.5 months, compared to 6.9 months for Opdivo alone and 2.9 months for Yervoy alone.
The study is ongoing and will continue to evaluate the combo treatment for overall survival rates.
As part of the expanded label, the FDA also approved Opdivo for single-agent use in the treatment in BRAF mutation-positive advanced melanoma patients. The agency initially had asked for more data in a complete response letter issued in November 2015.
Last week, the U.K.'s health-costs regulator, the National Institute for Health and Care Excellence, supported the use of Opdivo for treatment of skin cancer. The regulator had previously rejected the inclusion of the drug for treating lung tumors because of its cost.
The endorsement from NICE is not final, however, and is being reviewed by its consultation group for final approval. Once that decision is made, the U.K.'s National Health Service is required to make the drug available to patients within three months. NICE's other decision rejecting Opdivo for lung cancer is also awaiting a final decision.
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