FDA
Agencies and drugmakers are struggling to generate consistent standards and regulatory criteria for evaluating autologous cell therapies.
FDA Approves Genentech's Tecentriq as Adjuvant Treatment for PD-L1-Expressing NSCLC
The agency also approved the Ventana PD-L1 Assay from Roche's Ventana Medical Systems as a companion diagnostic device.
FDA Approves First-Line Keytruda Combo for PD-L1-Expressing Cervical Cancer Patients
The agency approved Keytruda as a front-line option with chemo, with or without Avastin, and converted a second-line accelerated approval for the immunotherapy to full approval.
FDA Approves Eli Lilly's Verzenio as Adjuvant Therapy for High-Risk, Early Breast Cancer Patients
The decision follows results from the monarchE trial, in which the drug with endocrine therapy benefited early-stage breast cancer patients with a high Ki-67 score.
FDA Recognizes Portion of MSK Oncology Knowledge Base in Public Human Genetic Variant Database
MSK's OncoKB is the first collection of somatic variants that the FDA has accepted for test developers to use in premarket validation studies.