Roche Group member Genentech announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.
The U.S. Food and Drug Administration approved Eagle Pharmaceuticals’ Pemfexy (pemetrexed for injection) as a branded alternative to Eli Lilly and Co.’s Alimta.
Exploratory Analysis Shows Significant OS Results from Keytruda in KRAS MutationsBlockbusters, Checkpoint Inhibitors, Chemotherapy, Clinical Trials, European Society for Medical Oncology (ESMO), Exploratory Analysis, Keytruda, KRAS Mutations, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Monotherapy, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), R&D
Findings from the Phase III KEYNOTE-042 study show improvements in overall survival (OS), PFS and ORR in patients treated with Merck’s Keytruda (pembrolizumab) as a monotherapy.
The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended EU approval of Roche’s cancer immunotherapy Tecentriq in combination with chemotherapy as an initial treatment of adults with extensive-stage small cell lung cancer, the Basel, Switzerland-based company said.
Weekend Highlights from 2019 ASCO Annual MeetingAmerican Society of Clinical Oncology (ASCO), Analysis, Approvals, Clinical Data, Clinical Trials, Endocrine Therapy, Epidermal Growth Factor Receptor (EGFR), FDA, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Monoclonal Antibodies, Oncology, R&D, Relapse/Refractory Multiple Myeloma, Stage III non-small cell lung cancer (NSCLC), Unresectable
There was a flurry of activity during the first few days of the American Society of Clinical Oncology, with multiple presentations made showing the benefits of various oncology treatments.
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 cancerBlockbusters, FDA, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Supplemental Biologics License Application (sBLA), Therapeutics
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’s lung cancer combo treatment wins FDA approvalAccelerated Review, American Cancer Society, Approvals, Bladder Cancer, Blockbusters, Clinical Studies, Extensive-Stage Small Cell Lung Cancer, FDA, FDA/Regulatory, Immunotherapies, Lung Cancer, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Urinary Tract Cancer
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.