After sailing through a string of earlier FDA approvals, Bristol-Myers Squibb’s Opdivo has been turned down by the agency for a particular form of melanoma.
Last week, the US regulator gave the thumbs-up to Opdivo (nivolumab) as a first-line, single-agent treatment for patients with ‘wild-type’ BRAF melanoma, a group that does not generally respond to treatment with BRAF inhibitors such as Roche’s Zelboraf (vemurafenib).
It has previously also approved the combination of Opdivo and BMS’ CTLA4 inhibitor Yervoy (ipilimumab) as a therapy for BRAF wild-type melanoma patients.
Now, the FDA says it needs additional information before it can approve Opdivo as a single-agent therapy in patients whose tumours test positive for BRAF V600 mutations. About 50% of all melanomas harbour BRAF mutations, and 90% of these are BRAF V600E.
In a statement, BMS said it is trying “to determine whether additional data, currently under review, adequately addresses these comments”.
The company has already submitted data from its CheckMate-067 trial evaluating Opdivo as a single agent and in combination and Yervoy in patients with previously-untreated advanced melanoma, which included patients with both wild type and BRAF V600-positive tumours.
Data from this study has already been submitted to the FDA as part of a dossier seeking to expand the label for Opdivo and the Opdivo/Yervoy combination in advanced melanoma, with an FDA action date of January 23, 2016.
The FDA response is the first setback for the product, which has amassed several FDA approvals in recent months that have propelled sales to $467m in the first nine months of the year, the bulk of that ($300m-plus) in the third quarter.
Any brake applied to the drug’s momentum in melanoma is likely to be overcome by Opdivo’s recent approval in renal cell carcinoma, an indication estimated to be worth at least $1bn in sales in its own right.