Earlier this week, the FDA approved the oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (erlotinib) for the approximately 10% of advanced NSCLC patients with an activating EGFR mutation in North America and Europe (approximately 30% in Asia).   While that’s generally a good thing, and it’s in keeping with the evidence very strongly supporting erlotinib or another EGFR TKI as the optimal systemic therapy for patients with an activating EGFR mutation, the indication was paired with a positive result on a specific mutation test marketed by Roche called cobas and used in the EURTAC trial of Tarceva vs. chemo that was conducted in Europe on patients with an activating EGFR mutation on the Roche test that was approved to be paired with the first line Tarceva indication.

I’m concerned that this development may well be detrimental for patients, even if it’s a shrewd move for Roche.  Why? Because there is already a clear consensus that EGFR TKI therapy is the preferred treatment for patients with an activating EGFR mutation, and the evidence supporting it is so overwhelmingly compelling that it’s uncommon to have erlotinib refused by payers as the treatment of choice in EGFR TKI-naive patients, even before the official FDA approval.  Moreover, over the past 9 years since activating EGFR mutations were first identified, a wide range of different tests to detect them have been used.  We know that the excellent responses with EGFR TKIs are seen primarily in patients with the more common exon 19 and exon 21 mutations, which are the ones specifically detected with the cobas test from Roche, but many other testing platforms can do this quite well and have been used for years and years now to identify patients who are great candidates for early EGFR TKI therapy.  

By linking the indication for first line Tarceva in EGFR mutation-positive patients with a positive result on the cobas test, Roche may well have enforced a monopoly on molecular testing, but there is no reason to think that their test is meaningfully better than many other options.  To me, this move seems as crass and transparently commercial at the expense of good science and care as seeking an FDA approval that erlotinib needs to be taken daily with a venti Starbucks latte if Starbucks had wrangled their way into a strategic partnership and got written into the EURTAC protocol.  My fear is that many people who have had EGFR mutation testing done by other reputable sources will now have their opportunity to receive first line Tarceva jeopardized based on the linked approval of the indication with the test.  Some people may require additional biopsies and incur treatment delays, increased risks, and added costs just because Roche finagled an opportunistic rider on the science.

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