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.
Cancer Screening and Diagnoses in Northeast Return to Pre-COVID-19 Levels
March 18th 2021Although cancer screening rates and ensuing diagnoses dropped significantly during the height of the COVID-19 pandemic, testing rates from June 2020 through September 2020 have nearly returned to pre-pandemic levels.
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.
Study Explores Actionable Pathologic Variants in Caribbean Women With Breast or Ovarian Cancer
March 11th 2021One in 7 Caribbean-born individuals with either breast or ovarian cancer had hereditary disease with an actionable pathogenic variant, which provides the opportunity for the utilization of targeted therapeutics and precise prevention strategies.
PARP Inhibitors Are a Mainstay in Metastatic Breast Cancer
March 8th 2021Olaparib and talazoparib didn't show statistically significant improvements in overall survival compared with chemotherapy in certain patients with metastatic breast cancer. However, the results are unlikely to affect the drugs’ utility in practice, given that both agents continue to show favorable tolerability and disease control.