FDA has approved quizartinib (Vanflyta) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test.
FDA has granted Fast Track designation to Ambrx’s proprietary anti-PSMA antibody-drug conjugate investigational therapy, ARX517, for the treatment of patients with metastatic castration-resistant prostate cancer upon progression on an androgen receptor pathway inhibitor.
As researchers consider using circulating tumor DNA as an endpoint in clinical trials to evaluate drug efficacy, a collaboration led by Friends of Cancer Research is creating the evidentiary roadmap for the use of ctDNA in regulatory decisions.
FDA has established the Oncology Quality, Characterization and Assessment of Real-World Data initiative.
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.
