Merck's Pembrolizumab Receives FDA Accelerated Approval
Merck announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Keytruda (pembrolizumab) for the treatment of patients with advanced or unresectable melanoma. Keytruda is the first anti-PD-1 therapy approved by the FDA.
Pembrolizumab is a humanized monoclonal antibody that blocks the cellular pathway PD-1, known to keep the body’s immune system from attacking and killing melanoma cells. The drug was approved for melanoma patients who are unresponsive to ipilimumab and BRAF inhibitor if the disease is BRAF V600 mutation positive. Keytruda previously received Breakthrough Therapy designation and has been approved almost two months ahead of its schedule in October, the FDA says.
“The accelerated FDA approval of Keytruda is a meaningful development for patients with advanced melanoma. Our new ability to target the PD-1 pathway with Keytruda is a very exciting step in the immunotherapy field,” said Dr. Omid Hamid, Director of the Melanoma Center at The Angeles Clinic and Research Institute, and a lead investigator for the pembrolizumab melanoma clinical trial.
Melanoma is responsible for around 5 percent of all new cancers cases in the U.S. Around 76,100 will be diagnosed and 9,710 will die of the disease this year in the country, says the National Cancer Institute. “Keytruda is the sixth new melanoma treatment approved since 2011, a result of promising advances in melanoma research. Many of these treatments have different mechanisms of action and bring new options to patients with melanoma,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Reuters reports that the drug will be priced at about $12,500 a month, which Merck says “is consistent with other innovative oncology medicines.” However, concerns have been raised regarding the price of anti-PD-1 treatments, such as Keytruda and Opdivo (nivolumab), the latter of which was recently revealed to be priced at a steep $143,000 per year by Bristol-Myers Squibb’s Japan partner Ono Pharmaceutical.