Merck's Keytruda gets FDA approval for treatment of malignant melanoma

Decision Resources GroupSep 10 2014

The recent approval of Merck & Co.'s Keytruda by the U.S. Food and Drug Administration for the treatment of malignant melanoma is a significant milestone for Merck & Co. and for the oncology immunotherapy drug market. Decision Resources Group anticipates the launch of Keytruda as the first anti-PD-1 immunotherapy in the United States for treatment of advanced and unresectable malignant melanoma. Decision Resources Group will track the launch of Keytruda throughout its first year on the market through our syndicated LaunchTrends report series.

Keytruda's approval is a major event in oncology:

• First PD-1 inhibitor: With this approval, Keytruda will be the first anti-PD-1 immunotherapy that will launch in the U.S. malignant melanoma market.
• Rapid path to market: After being granted breakthrough therapy designation status in April 2013, Merck & Co. initiated a rolling submission to the FDA in January 2014. By May 2014, the FDA granted Keytruda priority review and on September 4, 2014, it secured accelerated FDA approval. Keytruda's approval comes nearly two months ahead of its PDUFA date (October 28, 2014).
• Competing U.S. therapies: Keytruda is the sixth therapy to receive approval for malignant melanoma in the United States and will expand the variety of treatment options for malignant melanoma patients who have previously received Bristol-Myers Squibb's Yervoy and a BRAF/MEK inhibitor if a patient is BRAF V600-mutation-positive.

Comments from Decision Resources Group Senior Director Rachel Webster, M.A., M.Sc., D.Phil.:

• "The FDA approval of Keytruda has come much earlier than expected. As the first anti-PD-1 agent to reach the U.S. market, this approval marks a significant milestone for cancer immunotherapy and paves the way for a new wave of novel targeted therapy."
• "Keytruda is expected to greatly diversify the treatment armamentarium for malignant melanoma. With high response rates and impressive durability, Keytruda promises to be a competitive force in the increasingly dynamic malignant melanoma market."