Merck’s Immuno-oncology drug Keytruda (pembrolizumab) has been scheduled for priority review by the Food and Drug Administration (FDA) for its latest indication, meaning it should have a decision from the US drug agency by the end of the year. Drugs under Priority Review are assessed within a six month window, rather than the conventional ten months.
The drug is currently being reviewed for use in Merkel cell carcinoma, potentially adding to its swathe of current FDA approvals including for subsets of patients with melanoma, cervical cancer, lymphoma, and non small cell lung cancer. The latter review was conducted under the Real-Time Oncology Review Pilot Programme.
Approval for Keytruda would put it in competition with Bavencio (Avelumab) in the US, which is the only currently available treatment for the disease (owned by Pfizer and Merck’s parent company). This drug itself was fast-tracked via the FDA’s accelerated approval process, which allows conditional approval based on surrogate endpoints for drugs addressing unmet clinical need.