FDA approved Braftovi (encorafenib) with Mektovi (binimetinib) for adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
A novel study led by Friends of Cancer Research is providing evidence that tumor response rates can be assessed across real-world data sets, bringing regulators one step closer to potentially building a framework for pre-market evaluation of cancer drugs and post-market tracking of drug performance based on real-world endpoints.
The FDA Oncologic Drugs Advisory Committee concurred with the FDA staff that the Amgen Inc. confirmatory trial of the lung cancer therapy sotorasib (Lumakras) was uninterpretable as a result of a perceived loss of equipoise.
The FDA Oncologic Drugs Advisory Committee Oct. 4 voted decisively to recommend the first-ever approval supported by a clinical trial that relied on an external control arm—using patient-level data extracted from another trial.
FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers.Â
FDA has accepted for priority review the Biologics License Application for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies.Â
FDA proposed a rule seeking to amend FDA’s regulations to make explicit that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.Â
FDA is taking steps to help further accelerate the development of novel drug and biological products for rare diseases.Â
Nearly 80% of NIH staff will be furloughed if Congress fails to fund the federal government or pass a continuing resolution before midnight Saturday, Sept. 30—halting many administrative functions and nonclinical activities in the agency’s research pipelines.
FDA has approved Bosulif (bosutinib) for pediatric patients ages one year and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed or resistant or intolerant (R/I) to prior therapy.Â