FDA Reprimands Genentech for “Drastically Overstat[ing] the Efficacy of Tarceva”

by Jonathan J. Darrow

On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva.  Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter).  A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .”  Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year.  A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.

The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days.  The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.”  (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.”  Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.”  The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.

The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.

This entry was posted in Bioethics, Biotechnology, Empirical, End-of-Life, FDA, Health Law Policy, Intellectual Property, Jonathan Darrow, Liability, Medical Quality, Medical Safety, Public Health by jdarrow. Bookmark the permalink.

About jdarrow

Dr. Jonathan J. Darrow is a research fellow at Harvard Medical School and a post-doctoral fellow in the Program on Regulation, Therapeutics and Law at Brigham & Women’s Hospital. He holds a BS in biological sciences from Cornell, a JD from University, an MBA from Boston College, and an SJD (a dissertation-based doctorate and the law discipline’s highest degree) from Harvard, where he also completed the LLM program in 2009. After admission to the bar, Dr. Darrow practiced law in the Silicon Valley offices of Cooley Godward and later worked on patent litigation matters at Wiley Rein & Fielding in Washington, DC. He is admitted to practice before the USPTO and has served on the business law faculties of Boston College, Plymouth State University, and Bentley University (current). His legal scholarship on technology, intellectual property, and health has appeared in numerous publications including the New England Journal of Medicine, the Journal of Law, Medicine & Ethics, the Stanford Technology Law Review, the NYU Journal of Legislation & Public Policy, the Northwestern Journal of Technology & Intellectual Property, and the Harvard Journal of Law & Technology, among many others. He is a co-author of two major law textbooks: Cyberlaw: Text and Cases and The Legal and Ethical Environment of Business. Dr. Darrow previously explored the impact of intellectual property on global health during stints at both the World Trade Organization and World Health Organization in Geneva, Switzerland.