FDA granted full approval to Keytruda for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.Â
FDA issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for approval of oncology drugs in part due to the serious and life-threatening nature of cancer and because of available intermediate clinical endpoints likely to predict clinical benefit.
FDA granted accelerated approval to Zynyz (retifanlimab-dlwr) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
FDA approved Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.
The FDA Oncologic Drugs Advisory Committee March 9 voted 11:2 in favor the approval of Polivy (polatuzumab vedotin-piiq) in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for treatment-naive diffuse large B-cell lymphoma.
FDA has approved an expanded indication for Eli Lilly and Company’s Verzenio (abemaciclib), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence.
FDA approved Roche’s VENTANA PD-L1 (SP263) assay as a companion diagnostic to identify non-small cell lung cancer patients eligible for treatment with Libtayo (cemiplimab), based on the results of the Phase III EMPOWER-Lung study.
FDA approved a single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. The Udenyca autoinjector has a streamlined, easy-to-use design for use in both in-office and at-home settings of care.
FDA published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.
FDA’s Center for Tobacco Products published the actions it plans to take in response to an external evaluation commissioned last year from an independent panel of evaluators working through the Reagan-Udall Foundation.
