Patrick Considine of Diaceutics comments on the recent approvals of Tarceva® and Gilotrif™, highlighting that the approval of Tarceva® for Roche is an interesting and potentially trend-setting new lifecycle management approach.
In May and July of 2013, respectively, the FDA approved two targeted therapies for non-small cell lung cancer, Tarceva® (erlotinib, Roche) and Gilotrif™ (afatinib, Boehringer Ingelheim). In both cases, they were concurrently approved with a proprietary companion diagnostic test (CDx) that detects EGFR exon 19 deletions or exon 21 L858R substitution gene mutations.
It is noteworthy that in both cases the use of CDx tests identified metastatic NSCLC sub-populations that best responded to the therapies and enabled FDA approvals for first-line treatment. In the case of Gilotrif™, such a first-line indication was indeed achieved at its first approval, a remarkable achievement in NSCLC. In contrast, Tarceva® received its original FDA approval in 2004 for use in a broad, untargeted NSCLC population and “after failure of at least one prior chemotherapy regimen” only. Its recent new approval for first-line use in EGFR mutation-positive patients illustrates an interesting and potentially trend-setting new lifecycle management approach by Roche.