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FDA Approves Merck’s KEYTRUDA® (Pembrolizumab) As First-Line Combination Therapy With Pemetrexed And Carboplatin For Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective Of PD-L1 Expression

(Merck) May 10, 2017 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta®) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression.

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H. Jack West, MD (Posted: May 10, 2017)

quotesThis is a weak approval based on disappointingly scant evidence, especially considering that 37 of 123 patients (30%) enrolled had 50% or greater PD-L1 expression and would now be considered as having pembrolizumab monotherapy as standard of care. With the phase III KEYNOTE-189 with the same trial design but larger, and already completed (as well as many other trials of chemo +/- checkpoint inhibitor therapy), it is disappointing that we saw such a rush to judgment. It should be viewed as putting marketing ahead of true evidence. Perhaps the more mature overall survival data (not highlighted in the press release) are more compelling now than at the time of the initial presentation and publication in October, 2016. Unfortunately, I'm afraid we will soon see that the FDA functions merely to rubber stamp marketing efforts with the slightest pretense of evidence to support commercial interests, rather than to offer a critical review of the true value of unfathomably expensive treatments that provide technically positive results on watered down endpoints.quotes

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