FDA has approved rucaparib (Rubraca) for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy.Â
FDA and OS Therapies held a Type C meeting regarding the phase IIb human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma.Â
FDA has awarded a National Priority Voucher to teclistamab (Tecvayli) in combination with daratumumab (Darzalex) for relapsed/refractory multiple myeloma. This brings the total number of products receiving an award under the Commissioner’s National Priority Voucher pilot program to 16.
The European Commission has approved Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (Grade 1-3a) after at least one line of systemic therapy.
FDA published a perspective article in JAMA that describes the agency’s current regulatory thinking for the development of CAR T-cell therapies.Â
FDA approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner’s National Priority Voucher pilot program, marking the first approval achieved through this review pathway.
FDA granted Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab and hyaluronidase-fihj) Breakthrough Therapy designation as second line for patients with relapsed/refractory multiple myeloma.Â
FDA has cleared the Hugo robotic-assisted surgery system for use in urologic surgical procedures.Â
FDA approved a new indication for Breyanzi (lisocabtagene maraleucel) as the first CAR T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma who have failed treatment with or relapsed after two or more prior lines of therapy.Â
FDA approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.
