Junshi Biosciences announced that the Phase III clinical trial the Chinese pharmaceutical company is conducting alongside California-based Coherus BioSciences on a potential non-small cell lung cancer (NSCLC) drug is showing positive preliminary results.
Findings from the Phase III EMPOWER-Lung 3 trial, announced Aug. 5 by Regeneron Pharmaceuticals and Sanofi, show that a combination regimen comprising the PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved overall survival compared with chemotherapy alone in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC).
Traditional management tools have proven to be ineffective at managing costs for oncology drugs, leading to a hands-off management approach in the United States. But a recent survey from Two Labs – including 25 Pharmacy Directors and Medical Directors at US insurance companies representing 112.5 million covered lives – shows that the situation might be changing. The survey aimed to gather insight about what the industry looks like with increased levels of care management by covering traditional management tools, oncology-specific tools, systemic management tools and shifting risk, value frameworks, and pathways of care.
The U.S. Food and Drug Administration made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.
Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved the PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. The EC also approved Libtayo in advanced basal cell carcinoma (BCC).
The U.S. Food and Drug Administration on May 28 approved Amgen Inc.’s drug Lumakras for lung cancer patients with a specific mutation in a gene known as KRAS whose disease has worsened after treatment with chemotherapy or other medicines.
Biotech firm Beigene Ltd. said on May 21 the company’s cancer therapy, tislelizumab, in combination with chemotherapy met the main goal of helping patients live longer by preventing the disease from progressing in a late-stage study.
Amgen announced data from the Phase II cohort of the CodeBreaK 100 trial of sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer.
The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
While the world has largely been focused on the development of vaccines and therapeutics for Covid-19, the U.S. Food and Drug Administration has remained busy lining up potential approvals of medications for other diseases and illnesses.