FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older
Astellas Pharma Inc. announced that FDA has acknowledged the company’s resubmission of the Biologics License Application for zolbetuximab, a first-in-class investigational claudin 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive.
FDA’s Medical Devices Advisory Committee has strongly recommended FDA approval of Guardant Health’s Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease.
FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
FDA has reassigned the previously announced Prescription Drug User Fee Act goal date of Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20).
FDA Oncology Center of Excellence has formed the OCE Equity Program.
Sen. Richard J. Durbin (D-IL) has asked Amgen to provide copies of the company’s communications with FDA related to the dosage of Lumakras (sotorasib), a KRAS inhibitor marketed under an accelerated approval for non-small cell lung cancer.
FDA and the European Medicines Agency granted an Orphan Drug Designation to Carthera for the use of carboplatin when used with SonoCloud technology in the treatment with malignant glioma.
If the FDA Oncology Center of Excellence (OCE) began an “innovation challenge” in oncology drug development, what would that look like?
FDA has accepted the Bristol Myers Squibb’s Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20)—herein referred to as “subcutaneous nivolumab”—across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
