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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Merck and Co Inc | NYSE:MRK | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
-0.88 | -0.68% | 127.92 | 129.76 | 127.985 | 129.76 | 7,446,078 | 01:00:00 |
The U.S. Food and Drug Administration approved Merck & Co.'s Keytruda for the treatment of the most common form of lung cancer, the second in a new wave of immune-boosting drugs to be cleared for one of the deadliest cancer types.
The FDA also approved a companion diagnostic from Dako North America, which tests for a substance on tumor cells known as PD-L1, to screen for patients who should receive Merck's Keytruda. A Merck-funded study found that Keytruda worked better in patients with higher levels of PD-L1 than in patients with lower or undetectable levels.
Merck shares declined 1.4% on the news because the FDA requirement that Keytruda should be used in PD-L1-positive patients could limit the population of patients using the drug.
Keytruda now joins rival Bristol-Myers Squibb Co.'s Opdivo as a new treatment option for certain patients with non-small cell lung cancer, which accounts for about 85% to 90% of all lung-cancer cases. The FDA approved Opdivo to treat a subtype of lung cancer in March and is expected to decide by January whether to expand Opdivo's use to a wider group of lung-cancer patients.
Both Keytruda and Opdivo work by blocking a substance on immune cells known as PD-1, lifting a natural brake on the immune system and allowing it to kill cancer cells. Doctors believe the anti-PD-1 drugs have potential to transform treatment of multiple tumor types, based on clinical trials showing improvements in survival and tumor-shrinkage rates versus some older treatments.
Analysts estimate the class has multibillion-dollar sales potential—fueled by hefty prices. Keytruda and Opdivo both cost about $12,500 a month per patient, or $150,000 if used for a full year.
On Thursday, the FDA approved the use of a combination of Opdivo and an older Bristol immunotherapy, Yervoy, for the treatment of melanoma. The treatment would cost about $256,000 for the first full year.
Write to Peter Loftus at peter.loftus@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
October 02, 2015 14:45 ET (18:45 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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