FDA Approves Dostarlimab for dMMR Advanced Endometrial Cancer
April 22nd 2021The FDA approved dostarlimab (Jemperli) for the treatment of patients with recurrent or advanced endometrial cancer that progressed on or after platinum-containing chemotherapy and whose cancer is DNA mismatch repair deficient (dMMR), as determined by an FDA-approved test.
FDA Approves Sacituzumab Govitecan for Previously Treated Metastatic Urothelial Cancer
April 13th 2021The FDA granted an accelerated approval to sacituzumab govitecan (Trodelvy) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously had a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
FDA Authorizes Marketing for AI Colon Cancer Detection Device
April 12th 2021The FDA has authorized the marketing of the first device that utilizes artificial intelligence based on machine learning to help clinicians detect lesions like polyps or suspected tumors in the colon in real time during a colonoscopy.
FDA Approves Additional Cetuximab Dose for KRAS Wild-Type, EGFR-Expressing CRC, Head and Neck Cancer
April 7th 2021The FDA has approved a new biweekly dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.
FDA Approves Isatuximab Plus Carfilzomib/Dexamethasone for Relapsed/Refractory Myeloma
March 31st 2021The FDA has approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received 1 to 3 lines of therapy.
FDA Approves Daunorubicin/Cytarabine for Pediatric AML Treatment
March 31st 2021The FDA has approved a revised label for daunorubicin/cytarabine (Vyxeos) to include the treatment of pediatric patients aged 1 year and older with newly diagnosed, therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.
FDA Defers Decision on Pembrolizumab for TNBC: Here's Why
March 30th 2021Ahead of the Prescription Drug User Fee Act action date for the application, the regulatory agency’s Oncologic Drugs Advisory Committee voted 10 to 0 that a decision be deferred until further findings from KEYNOTE-522 trial become available.
FDA Approves Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma
March 29th 2021The FDA has approved idecabtagene vicleucel as the first BCMA-directed CAR T-cell therapy for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
FDA Approves Pembrolizumab for Advanced Esophageal/GEJ Cancer
March 22nd 2021The FDA has approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation.
Belzutifan Granted Priority Review for VHL Disease–Associated RCC
March 17th 2021The FDA has granted priority review to the new drug application for the HIF-2α inhibitor belzutifan for the potential treatment of patients with von Hippel-Lindau–associated renal cell carcinoma that does not require immediate surgery.
FDA to Reassess Accelerated Immunotherapy Approvals
March 12th 2021Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.
Tipifarnib Gets Breakthrough Therapy Designation for HRAS-Mutated HNSCC
February 25th 2021The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma with variant allele frequency of 20% or higher following progressive disease on platinum-based chemotherapy.
Vicineum Granted Priority Review for High-Risk, BCG-Unresponsive Bladder Cancer
February 18th 2021The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.
Sotorasib Granted Priority Review for KRAS G12C–Mutated Advanced or Metastatic NSCLC
February 17th 2021The FDA has granted priority review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, after at least 1 previous systemic therapy.
FDA Approves Trilaciclib for Chemo-Induced Bone Marrow Suppression in Small Cell Lung Cancer
February 12th 2021The FDA has approved trilaciclib to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.