FDA Grants Bristol-Myers Squibb's Opdivo Accelerated Approval for Melanoma

December 22, 2014

The FDA approved Bristol-Myers Squibb’s Opdivo (nivolumab) injection, for intravenous use. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Metastatic melanoma is the deadliest form of skin cancer, and despite recent advances, there are limited treatment options available for patients who have been previously treated with approved agents.

“Bristol-Myers Squibb is pleased to be able to offer an important new option for patients who have progressed following treatment for unresectable or metastatic melanoma, which is one of the most aggressive forms of cancer,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “The approval of Opdivo, the latest breakthrough medicine from our immuno-oncology pipeline, demonstrates our company’s commitment to meeting the needs of these patients, and to leading advances in the science of immuno-oncology.”

Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, nephritis and renal dysfunction, hypothyroidism and hyperthyroidism, other adverse reactions; and embryofetal toxicity.

The company expects to begin shipping Opdivo within one to two weeks of today’s approval.

Opdivo is the only PD-1 that has demonstrated efficacy in a Phase III, pivotal clinical trial with advanced melanoma in patients who had been previously treated and progressed with Yervoy and, if BRAF mutation positive, a BRAF inhibitor. The efficacy of Opdivo was evaluated based on a single-arm, non-comparative planned interim analysis of the first 120 patients who received Opdivo with a minimum of six months follow-up in the Phase III CheckMate -037 trial.

Opdivo achieved a 32 percent response rate (38/120) with a dosing strength and frequency of 3mg/kg intravenously over 60 minutes every two weeks. Three percent of patients (4/120) achieved a complete response, and 28 percent (34/120) achieved a partial response. Of 38 patients with responses, 33 patients (87 percent) had ongoing responses with durability of response ranging from 2.6+ to 10+ months, which included 13 patients with ongoing responses of 6 months or longer. Responses to Opdivo were demonstrated in both patients with and without BRAF mutation.

The safety profile of Opdivo has been demonstrated in the pivotal, Phase III CheckMate-037 trial. Serious adverse reactions occurred in 41 percent of patients receiving Opdivo. Grade 3 and 4 adverse reactions occurred in 42 percent of patients receiving Opdivo. The most frequent Grade 3 and 4 adverse drug reactions reported in 2 percent to <5 percent of patients receiving Opdivo were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. The most common adverse reaction (greater-than or equal to 20 percent) reported with Opdivo was rash (21 percent).

“The approval of Opdivo gives patients and physicians an important new treatment option for a population where they were once very limited,” said Jeffrey S. Weber, MD, PhD, director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt Cancer Center. “For the first time, a PD-1 blocking antibody has shown a response rate of 32 percent in a Phase III randomized clinical trial of patients with unresectable or metastatic melanoma, who have progressed following first line therapy.” Efficacy was evaluated in a single-arm, non-comparative, planned interim analysis of the first 120 patients who received Opdivo in the CheckMate -037 trial in whom the minimum duration of follow up was six months.

“The emergence of effective immuno-oncology therapies that are capable of successfully treating metastatic melanoma has reinvigorated the field of cancer immunology with an optimism that immune based treatments will play a central role in therapeutic strategies for cancer patients,” said Jill O’Donnell-Tormey, PhD, CEO and director of Scientific Affairs at the Cancer Research Institute, a nonprofit organization dedicated to advancing the science of cancer immunology.

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