Roche received European Commission (EC) approval for the company’s Tecentriq drug in combination with Avastin and chemo as an initial treatment for people with a specific type of lung cancer.
FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy for initial treatment of metastatic non-squamous non-small cell lung cancer
Roche announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq in combination with Abraxane and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations.
South San Francisco-based Genentech filed with the State of California, indicating that the Roche company planned to cut 83 jobs.
Roche Holding AG’s Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer.
Shares of OncoMed Pharmaceuticals fell after the company announced that Celgene walked away from a deal to license the bispecific antibody navicixizumab.
Merck & Co.’s key cancer drug Keytruda was approved for use in Europe in combination with chemotherapy in previously untreated lung cancer patients.
Roche said the U.S. FDA extended by three months the review period for Tecentriq in combination therapy as a first-line treatment for a form of lung cancer.
The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial.
FDA Grants Priority Review to Merck’s Supplemental BLA for Keytruda in Combination with Chemo as First-Line Treatment for Metastatic Squamous NSCLC
The U.S. FDA accepted for review Merck’s supplemental Biologics License Application for the anti-PD-1 therapy Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression.