Sunday, September 7, 2014


FDA approves new immunotherapy for melanoma.

There was wide coverage of the news that Merck & Co. on Thursday received FDA approval for a novel cancer medication called Keytruda (pembrolizumab), with major newspapers, news agencies and trade journals reporting. Many media outlets highlighted the significance of the medication, noting that Keytruda belongs to a new class of medications for treating advanced melanoma, using the body’s own immune system. The Wall Street Journal (9/5, Loftus, Subscription Publication) discusses the importance of the approval, noting that it is aimed at treating patients who have exhausted other therapies, including those people who did not respond adequately to Bristol-Myers Squibb Co.’s immunotherapy Yervoy (ipilimumab).
        Writing about the mechanism of action of the new therapy, the New York Times (9/5, Pollack, Subscription Publication) reports that cancer researchers have been struggling to solve how cancerous cells manage “to evade the body’s immune system” and the “answer is that tumors activate brakes on the immune system, preventing it from attacking them.” The paper notes that Keytruda “is the first drug approved that inhibits the action of one of those brakes, a protein known as PD-1, or programmed death receptor 1.” The Times notes that the general approach could “work for many types of cancer, though so far the main successes in clinical trials have come against the deadly skin cancer melanoma, lung cancer and kidney cancer.”
        Discussing the results of trials that facilitated the approval of the medicine, the Los Angeles Times (9/5, Healy) reports the FDA disclosed Keytruda “showed promising early results in 173 clinical trial participants with advanced melanoma whose disease progressed after prior treatment.” About a quarter who were given one of two doses of Keytruda “saw their tumors shrink.” According to the piece, “the effect lasted at least 1.4 to 8.5 months and continued beyond this period in most patients.”
        According to Bloomberg News (9/5, Edney, Koons)melanoma “accounts for 2 percent of skin cancer cases and causes the majority of deaths from the disease,” including nearly 10,000 expected this year, citing the American Cancer Society. The article notes that the treatment “was approved under the FDA’s accelerated approval program,” but Merck will still have to show “the benefits through an improvement in survival or disease-related symptoms.”
        The treatment, however, does not come cheap, with “early shipments” of Keytruda costing “$112,000 a year for an average patient,” and later versions reaching $150,000 a year, reports the Philadelphia Inquirer (9/5), citing Bernstein Research analyst Tim Anderson. In a note to clients Thursday Anderson expects “that Merck’s sales from Keytruda will be about $3.5 billion in 2020,” the paper adds.