Bristol-Myers
Oncology Drug Opdivo Receives FDA Approval - Analyst Blog
Bristol-Myers
Squibb Company ( BMY ) announced that the FDA has cleared its intravenous human
programmed death receptor-1 (PD-1) blocking antibody, Opdivo for the treatment
of patients suffering from unresectable or metastatic melanoma and disease
progression following Yervoy and, if BRAF V600 mutation positive, a BRAF
inhibitor.
Opdivo
gained accelerated approval for the melanoma indication based on tumor response
rate and the durability of response. Full approval for this indication depends
on verification and description of clinical benefit in the confirmatory trials.
The
company plans to start shipping the drug in next few weeks.
Opdivo
is being studied in several oncology indications, such as, renal cell
carcinoma, head and neck cancer, glioblastoma and non-Hodgkin lymphoma. We note
that Opdivo is already approved in Japan for treating patients with
unresectable melanoma.
The
candidate is under review in the EU for the advanced melanoma and non-small
cell lung cancer (NSCLC) indications. The company is also looking to get Opdivo
approved for NSCLC in the U.S.
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