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.
Comprehensive Assessment Is Key for Geriatric Patients
April 8th 2021The information provided by the assessment is essential as it contributes to shared decision making. The goal of shared decision-making is for patients and clinicians to partner together and make informed choices based on the patient’s needs, values and preferences.
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.
Futibatinib Granted Breakthrough Therapy Designation for FGFR2+ Advanced Cholangiocarcinoma
April 2nd 2021The FDA has granted a breakthrough therapy designation to the FGFR inhibitor futibatinib for the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma that harbors FGFR2 gene rearrangements, including fusions.
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.