NCI has awarded LoxiGen Inc. a three-year Fast-track Small Business Technology Transfer grant to develop a drug that targets treatment-resistant triple-negative breast cancer.Â
FDA approved Talzenna (talazoparib) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.Â
FDA established a voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients.
Flatiron Health is partnering with Leeds Teaching Hospitals NHS Trust, one of largest acute hospital trusts in Europe. “Alongside partners, regulators, and patient advocates—and with scalable and secure methods—Flatiron has developed a unique offering in the UK to translate data from routine clinical care into research-ready datasets,” Flatiron CEO Carolyn Starrett said in a statement.... […]
FDA accepted the New Drug Application for capivasertib in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.Â
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.Â
FDA has approved commercial production at the Bristol Myers Squibb’s cell therapy manufacturing facility in Devens, MA.Â
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.
