The agency reviewed data from the MARIPOSA-2 trial and approved the regimen for patients with common EGFR mutations who are progressing on EGFR inhibitors.
The bill's passage through the committee improves the rare pediatric disease priority review voucher program's chances of being reauthorized before it expires Sept. 30.
The French firm has a lead metastatic colorectal cancer vaccine candidate headed for Phase I/IIA trials, in which it will explore ways of predicting response.