Following a positive recommendation from the EMA committee, the European Commission is expected to issue a decision in September regarding marketing Tarceva as a first-line treatment for EGFR-mutation-positive NSCLC.
In particular, the study indicates that the technology's limit of detection is not yet sufficient to detect key low-abundance proteins and that it suffers from reproducibility issues that, while ultimately resolvable, could present significant practical obstacles in a clinical environment.
John Castellani, CEO of the Pharmaceutical Research and Manufacturers of America, said that while the industry's commitment to using genomic strategies to advance targeted therapies is growing, the road ahead is fraught with scientific, regulatory, and reimbursement challenges.
Data presented at ASCO this week showed that NSCLC patients with EGFR mutations who received Tarceva lived twice as long without their disease progressing compared to patients who received platinum-based chemotherapy, which is currently the standard of care for first-line NSCLC therapy.
"The median progression-free survival [with crizotinib] far exceeds anything that one would expect with standard therapy in this heavily pretreated group," Nasser Hanna of Indiana University said in a presentation at ASCO reviewing interim Phase I data on the drug.