Merck's potential blockbuster cancer drug approved

Posted: September 06, 2014

In a huge boost to the research efforts of drugmaker Merck & Co., the U.S. Food and Drug Administration on Thursday approved a new type of drug that unlocks the body's immune system to attack cancer cells.

Merck, which is based in Whitehouse Station, N.J., and employs thousands of people in Montgomery County, had staked much of its future hopes on approval and then sales, which analysts expect will generate billions of dollars a year.

The chemical name of the drug is pembrolizumab and its brand name will be Keytruda. Thursday's approval was for treatment of some patients with advanced melanoma, a type of skin cancer, but Merck hopes to build off this to treat other cancers.

The FDA decided it was important enough to put the evaluation on a fast track and this is the first U.S. approval for an anti-PD-1 (programmed death receptor-1) treatment.

"Keytruda embodies Merck's unwavering commitment to pursue breakthrough science to help people who are facing the most challenging diseases," Merck chief executive officer Ken Frazier said in a statement.

Several big drug companies have been racing to produce so-called immunotherapy medications, which are intended to release the brakes on the immune system to fight cancer cells.

Bristol-Myers Squibb's most promising candidate in this area, Nivolumab, was approved by Japanese regulators in July, but has not yet received FDA approval. BMS, which has big operations in Princeton, produces Yervoy, which is used to treat many melanoma patients. Merck's new drug is approved for use by patients who did not respond to Yervoy.

Bernstein Research analyst Tim Anderson wrote in a note to clients Thursday that he anticipated that early shipments of Merck's Keytruda will cost $112,000 a year for an average patient, but that later versions might reach $150,000 a year. Anderson projects that Merck's sales from Keytruda will be about $3.5 billion in 2020.

"The news of FDA's first approval of an anti-PD-1 drug is extremely exciting and shows just how far the field has come in the last few years," Debra Black, cofounder of the Melanoma Research Alliance, said in a statement. MRA receives some funding from pharmaceutical companies. "When we started MRA, there was little hope for melanoma patients. Today we are seeing a real sea change, with several new therapies and proof of concept that these new treatments can save lives."

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