ALK Mutations Archives

FDA Action Alert: Bristol Myers Squibb and Trevena

ALK Mutations, EGFR Mutations, European Medicines Agency, Fast Track Designation, FDA, FDA/Regulatory, Non-Small Cell Lung Cancer, Pain, Supplemental Biologics License Application, Tumors

August is a busy month on the U.S. Food and Drug Administration)’s calendar, including a target action date for Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab), dosed concomitantly with a limited course of chemotherapy, for the first-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

Opdivo-Yervoy Combo Snags Another FDA Approval for Lung Cancer

ALK Mutations, Approvals, Blockbusters, Chemotherapy, Double-Combination Therapies, EGFR Mutations, FDA, FDA/Regulatory, Metastatic non-small cell lung cancer, New Indications, Tumors

The FDA greenlit the combination therapy along with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-line Treatment of Certain People With Advanced Non-small Cell Lung Cancer

ALK Mutations, Biomarkers, Blockbusters, EGFR Mutations, FDA, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Metastatic Squamous Non-Small Cell Lung Cancer, PD-1/PD-L1 inhibitors, Priority Review, Supplemental Biologics License Application (sBLA)

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.