FDA’s Target Action Date for Merck’s Keytruda Is December 24
Why the FDA Granted Priority Review for Merck's Keytruda
Merck’s Keytruda
Keytruda is an immuno-oncology drug from Merck and Co (MRK). It is a human programmed death receptor protein 1 (PD-1) blocking antibody. This drug reduces tumor growth by blocking the interaction between PD-1 and its ligands. The drug treats non-small cell lung cancer as well as melanoma, a type of skin cancer.
The US Food and Drug Administration (or FDA) granted priority review for Keytruda for the treatment of patients with ipilimumab-refractory advanced melanoma with a PDUFA, or target action date, by December 24, 2015.
Uses of Keytruda
Keytruda is approved for the treatment of specific types of melanoma and non-small cell lung cancer (or NSCLC). For melanoma, Keytruda is used when the disease has spread and cannot be removed by surgery, the patient has not seen results from ipilimumab drug, and the patient has an abnormal BRAF gene but BRAF inhibitors do not work.
For NSCLC, Keytruda is used when cancer has spread and it tests positive for PD-L1, and neither platinum-based chemotherapy nor EGFR and ALK inhibitors help in the patient’s treatment.
Keytruda’s sBLA
Merck and Co. submitted a supplement biologics license application (or sBLA) to the FDA for Keytruda as a treatment for patients with advanced melanoma who are resistant to ipilimumab. As per the press release, Keytruda’s sBLA for ipilimumab-refractory advanced melanoma is based on the Keynote-002 study. We’ll discuss the details of the Keynote-002 study in the following articles.
Other drugs used for the treatment of advanced melanoma include Bristol-Myers Squibb’s (BMY) Opdivo and Yervoy, Novartis’s (NVS) Tafinlar and Mekinist, and Genentech’s Zelboraf. Other companies like AstraZeneca (AZN), AbbVie (ABBV), and Pfizer (PFE) also compete with Merck on different products. Investors can consider ETFs like the S&P 500 SPDR ETF (SPY), which holds ~0.8% of its investments in Merck, or the Health Care Select Sector SPDR ETF (XLV), which holds ~5.5% of its total investments in Merck, in order to divest company-specific risk.
Browse this series on Market Realist:
