FDA has accepted for review a new supplemental Biologics License Application seeking approval for Keytruda (pembrolizumab) in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
FDA has approved commercial production at the Bristol Myers Squibb’s cell therapy manufacturing facility in Devens, MA.
FDA has approved Lynparza (olaparib) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test (The Cancer Letter, May 5, 2023).
FDA approved Posluma (flotufolastat F 18), an optimized, high-affinity radiohybrid Prostate-Specific Membrane Antigen-targeted PET imaging agent. Posluma is indicated for positron emission tomography of prostate-specific membrane antigen-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.
FDA accepted the New Drug Application for repotrectinib, a next-generation tyrosine kinase inhibitor, for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer based on results from the phase I/II TRIDENT-1 trial. FDA granted the application priority review and assigned a Prescription Drug User Fee Act goal date of November 27.
The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended the approval of Opdivo plus platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%.
Lifebit and Flatiron Health are partnering to support vital research and enable scientific discoveries to improve and extend lives by learning from the experiences of people with cancer.
Leal, formerly known as Trialjectory, has established a proprietary platform for oncologists to quickly identify personalized clinical trial matches for their patients, reducing reliance on unstructured data and expediting patient treatment identification / clinical trial enrollment. The platform is free for oncologists.
FDA granted accelerated approval to Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
The Wistar Institute, the Pennsylvania Biotechnology Center, and the Baruch S. Blumberg Institute formed a collaboration to accelerate the advancement of “bench to bedside” biomedical research discoveries in Pennsylvania, New Jersey, and Delaware by collectively supporting the seeding, launching, and maturation of life science startups.
