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.
Numerous companies presented clinical trial data and updates at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
A therapy jointly developed by Switzerland’s Roche Holding AG and Cambridge, Mass.-based Blueprint Medicines Corp. was approved by the U.S. health regulator for the treatment of patients with a type of non-small cell lung cancer (NSCLC).
Eli Lilly is moving quickly to get the newly approved precision oncology treatment Retevmo for certain lung and thyroid cancers into the hands of patients.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
