Setting cancer drug dosage used to be easy: find the delicate balance between killing the disease and subjecting the patient to intolerable harm, and you are done.
FDA approved Talzenna (talazoparib) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.
A survey conducted by the National Comprehensive Cancer Network found that 93% of its 27 member institutions are experiencing shortages of carboplatin, and 70% lack cisplatin.
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.
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.
Today’s critical shortage of cisplatin and carboplatin occurred because manufacturers failed to invest in enhancing production capacity, Richard Pazdur, director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases, said to The Cancer Letter.
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.
FDA granted PYX-201 Orphan Drug Designation in pancreatic cancer.