FDA Grants Accelerated Approval for Bristol-Myers Squibb Company's Skin Cancer Drug Opdivo

FDA Grants Accelerated Approval for Bristol-Myers Squibb Company's Skin Cancer Drug Opdivo
December 23, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Bristol-Myers Squibb is enjoying a nice boost in its share price Tuesday, after the U.S. Food and Drug Administration said a day earlier that it will grant a pioneering approval for its melanoma drug Opdivo (nivolumab), the company’s main hope for treating the world’s most common form of skin cancer.

The approval was three months ahead of schedule and now allows clinicians to use Opdivo on patients with advanced skin cancers who already on Bristol-Myers’s Yervoy (ipilimumab).

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, in a statement. “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 widely considered by analysts to be the top therapeutic asset in Bristol-Myers pipeline, with an estimated cost of $12,500 per month, or around $150,000 annually--a massive boost to the company’s bottom line, particularly if it is approved for other uses.

That price is also comparable to its primary competitor, Merck ’s Keytruda, which like Opdivo, is a PD-1 inhibitor. PD-1 helps cancer cells masks their presence in the body, which allows them to grow and metastasize before the immune system can detect and attack them.

“The approval of Opdivo gives patients and physicians an important new treatment option for a population where they were once very limited,” said Jeffrey Weber, 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 3 randomized clinical trial of patients with unresectable or metastatic melanoma, who have progressed following first line therapy.”

The FDA approved the drug after was evaluating 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.

Opdivo is only the most recent melanoma therapy to come barreling out of the FDA’s approval process, as drugmakers rush to take advantage of what analysts have predicted to be a $35 billion a year market.

"Opdivo is the 7th new melanoma drug approved by the FDA since 2011," said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, told Fierce Biotech. "The continued development and approval of novel therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm for serious and life-threatening diseases."

Back to news