Genentech, a member of the Roche Group, on Thursday said the U.S. Food and Drug Administration approved Tecentriq and chemotherapy for some patients with a certain type of lung cancer.
Genentech said the FDA gave its approval to Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
Approval is based on results of the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer compared to Avastin and chemotherapy.
"This Tecentriq regimen has demonstrated a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development.
The company is working with the FDA on postmarketing commitments to better understand and characterize the potential effects of Tecentriq-related anti-drug antibodies and neutralizing antibodies.
--Write to Stephen Nakrosis at [email protected]