FDA expands approval of Bristol-Myers Squibb's Opdivo in melanoma

Bristol-Myers Squibb said Tuesday that the FDA expanded approval of Opdivo (nivolumab) to include use as a single agent for patients with previously untreated BRAF V600 wild-type unresectable or metastatic melanoma. Michael Giordano, head of oncology development at the company, remarked "Opdivo has become a critical part of the treatment landscape for advanced melanoma patients and their physicians, both as a monotherapy and in combination."

The decision was supported by data from the Phase III CheckMate -066 trial, with an interim analysis showing that Opdivo was superior on the primary efficacy endpoint of overall survival (OS), compared with dacarbazine, in the first-line treatment of patients with unresectable or metastatic BRAF wild-type advanced melanoma. The company indicated that median OS was not reached for the PD-1 inhibitor and was 10.8 months in the dacarbazine arm. With regard to secondary endpoints, median progression-free survival was more than double with Opdivo at 5.1 months, versus 2.2 months for patients in the dacarbazine group, while overall response rate was 34 percent and 9 percent, respectively.

Opdivo was first granted accelerated approval by the FDA last December for patients with unresectable or metastatic melanoma who no longer respond to other therapies. Last month, the US regulator cleared the drug in combination with Yervoy (ipilimumab) to treat patients with BRAF V600 wild-type unresectable or metastatic melanoma (for additional analysis, see ViewPoints: Bristol-Myers Squibb's Opdivo demonstrates irresistible momentum).

Other FDA-approved indications for Opdivo include advanced squamous and non-squamous non-small-cell lung cancer. Earlier this week, the PD-1 inhibitor was approved in the US for the treatment of metastatic renal cell carcinoma in patients who received a certain type of prior therapy.

Opdivo amassed $467 million in global revenue for the first nine months of 2015. Analysts have estimated that the PD-1 inhibitor class will eventually generate combined annual revenue in excess of $20 billion by 2020. For more information on cancer immunotherapies, see Cancer Immunotherapy: Payer Insight.

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