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This $94,000-a-Year Cancer Drug Caused Rashes and Rarely Worked. Now Trump Could Make FDA Approvals Even Easier

(Los Angeles Times) Feb 3, 2017 - In June, pharmaceutical giant Genentech sent doctors a letter saying they should no longer prescribe a blockbuster drug called Tarceva to most patients suffering from lung cancer.

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H. Jack West, MD (Posted: February 06, 2017)

quotesIt is disingenuous for the media to paint erlotinib (Tarceva) as a completely ineffective and inappropriately marketed drug when what actually happened was that the FDA approval was based on a significant overall survival benefit for erlotinib over supportive care in an unselected population (conducted before we even knew of EGFR mutations), followed by many subset analyses that demonstrated modest but consistent efficacy even in patients with squamous NSCLC (who almost never have EGFR mutations) and those with EGFR wild type. Was it remarkably effective? Not at all. Were oncologists enthusiastic about it? No. But it wasn't until a much later study indicated no significant benefit that one would definitely say that the preponderance of evidence shifted away from treatment of EGFR wild type patients with erlotinib. In addition, the EGFR mutation test is not perfect. I have had several patients who tested negative for an EGFR mutation on initial workup who later received 2nd or 3rd line erlotinib and enjoyed a spectacular, long-lasting response. In a few cases, later testing showed an EGFR mutation previously missed. Those patients would have almost certainly died years earlier without the benefit of the opportunity to receive erlotinib. Whether one was actually a proponent of EGFR TKI therapy in EGFR mutation-negative patients or not, it is revisionist history to act as if our current perspective should have been held based on the less extensive evidence available in the past. Moreover, oncologists, patients, and the mass media still regularly sensationalize treatments without a scintilla of evidence outside of a rare case of a patient doing well. It is the height of hypocrisy for these same oncologists, patients, and mass media to now act indignant that the level of evidence was insufficient to justify using erlotinib, while everyone clamors for off-protocol use of immunotherapy or other new therapies beyond current indications based on wild-eyed optimism and far, far less evidence.quotes

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