FDA Approves Sacituzumab Govitecan for Previously Treated Metastatic Urothelial CancerApril 13th 2021
The 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 DeviceApril 12th 2021
The 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 CancerApril 7th 2021
The 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 MyelomaMarch 31st 2021
The 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 TreatmentMarch 31st 2021
The 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 WhyMarch 30th 2021
Ahead 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 MyelomaMarch 29th 2021
The 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 CancerMarch 22nd 2021
The 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 RCCMarch 17th 2021
The 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 ApprovalsMarch 12th 2021
Six 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 HNSCCFebruary 25th 2021
The 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 CancerFebruary 18th 2021
The 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 NSCLCFebruary 17th 2021
The 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 CancerFebruary 12th 2021
The 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.
FDA Approves Cemiplimab for Advanced Basal Cell CarcinomaFebruary 9th 2021
The FDA approved cemiplimab-rwlc as the first immunotherapy for use in patients with advanced basal cell carcinoma that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.
FDA Approves Umbralisib for Relapsed/Refractory MZL and FLFebruary 6th 2021
The FDA approved umbralisib (Ukoniq) for the treatment of adults with relapsed/refractory marginal zone lymphoma (MZL) who had at least 1 prior anti-CD20—based regimen; and adults with relapsed/refractory follicular lymphoma (FL) who had at least 3 prior lines of systemic therapy.
Liso-Cel Approved for Refractory Large B-Cell LymphomaFebruary 6th 2021
The FDA has approved lisocabtagene maraleucel (Breyanzi) for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.