Potential New Trend-Setting Lifecycle Management Enabled by Personalized Medicine | Diaceutics

Potential New Trend-Setting Lifecycle Management Enabled by Personalized Medicine

July 16th, 2013

Patrick Considine

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. 

http://www.cancernetwork.com/lung-cancer/content/article/10165/2142929

https://www.diaceutics.com/arup-laboratories-and-labceutics-form-strategic-alliance-to-better-serve-personalized-healthcare-market/

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.

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