FDA's designation is based on phase 2 data presented earlier this year at the American Society of Clinical Oncology Annual Meeting.
FDA has granted priority review designation for Merck’s request for a supplemental biologics license application for pembrolizumab to treat Merkel cell carcinoma, a rare skin cancer. Merck announced the designation in a statement today.
Pembrolizumab, the anti-PD-1 therapy sold a Keytruda, is seeking accelerated approval based on data from a phase 2 study presented earlier this year at the American Society of Clinical Oncology Annual Meeting. That data from the KEYNOTE-017 trial, found that the objective response rate was 56%, including 24% who had a complete response rate and 32% with a partial response rate. Median overall survival had not been reached, compared with 9.5 to 10.2 months for chemotherapy. Median progression-free survival was 16.8 months which exceeded chemotherapy controls by more than a year.
“Merkel cell carcinoma, a rare type of skin cancer, is an aggressive and fast-growing disease that has been associated with mortality rates higher than other types of skin cancer, including melanoma,” said Scot Ebbinghaus, MD, vice president of clinical research at Merck Laboratories. “KEYNOTE-017 represents the longest observation to date of patients with advanced Merkel cell carcinoma receiving anti-PD-1 therapy in the first-line setting, and demonstrated durable tumor control in these patients.”
In July 2017, the treatment received Breakthrough Therapy designation for Merkel cell carcinoma. The Prescription Drug User Fee Act, or target action date, is December 28, 2018.
Pembrolizumab is already approved for multiple indications, that include certain patients with metastatic melanoma, certain types of non-small cell lung cancer (sometimes with or without chemotherapy), some patients with head-and-neck cancer; in patients with refractory classic Hodgkin lymphoma; and certain patients with primary mediastinal large B-cell lymphoma, urothelial carcinoma, gastric cancer, cervical cancer.