FDA declines expanded approval for Bristol-Myers' Opdivo drug

FDA declines expanded approval for Bristol-Myers' Opdivo drug

(Reuters) – Bristol-Myers Squibb Co said the U.S. Food & Drug Administration declined to approve its immuno-oncology drug, Opdivo, for its expanded use to treat an additional type of advanced skin cancer.

Bristol-Myers said it received a so-called complete response letter from the health regulator, which indicated the need for additional data in the BRAF mutated patient population.

The regulator issues a complete response letter when a new or generic treatment cannot be approved in its current form.

p> The FDA approved Opdivo as a single agent for the treatment of patients with BRAF V600 wild-type melanoma earlier this week, yet on Friday declined the approval of the drug for treating BRAF V600 mutation positive metastatic melanoma.

Opdivo, first approved in December 2014, raked in worldwide revenue of $467 million in the nine months ended Sept. 30.

The drug has been approved for five other indications in the past 12 months.

Metastatic melanoma is the least usual skin cancer. It is moreover the most deadly because it spreads (metastasizes) quickly & easily to other parts of the body.

(Reporting by Anya George Tharakan in Bengaluru; Editing Siddharth Cavale & Anil D'Silva)

Pharmaceuticals & Drug TrialsHealthBristol-Myers Squibb

Source: “Reuters”

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