Why the FDA Granted Priority Review for Merck's Keytruda
Drugs for advanced melanoma
As discussed earlier, the US Food and Drug Administration (or FDA) has granted priority review to Merck and Co’s (MRK) supplemental biologics license application (or sBLA) for Keytruda for the treatment of patients with ipilimumab-refractory advanced melanoma. The PDUFA, or target action date, is December 24, 2015.
Bristol-Myers Squibb’s Yervoy and Opdivo
Bristol-Myers Squibb’s (BMY) Yervoy is a drug indicated for the treatment of melanoma for cases where the tumor has spread and cannot be removed by surgery.
Opdivo is also used in the treatment of melanoma in combination with Yervoy for the treatment of patients with BRAF wild-type tumors. Opdivo is also indicated for the treatment of patients with non-small cell lung cancer and renal cell carcinoma.
Novartis’s Tafinlar and Mekinist
Novartis (NVS) acquired GlaxoSmithKline’s (GSK) oncology business in 2015. The drugs Tafinlar and Mekinist are used in combination for the treatment of patients with advanced melanoma with an abnormal BRAF gene where the tumor has spread and cannot be removed by surgery.
Other drugs
Intron A injection and Sylatron are some of the products from Merck used for the treatment of melanoma. Genentech’s Zelboraf is also used for the treatment of patients with advanced melanoma with an abnormal BRAF gene where the tumor has spread and cannot be removed by surgery. Another drug, Proleukin, is a product of Novartis (NVS) for the treatment of advanced melanoma. Prometheus Laboratories has the rights to distribute, promote, and sell Proleukin in the US.
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: