FDA approval history for Keytruda (pembrolizumab) used to treat Melanoma, Metastatic, Non Small Cell Lung Cancer, Head and Neck Cancer, Hodgkin's Lymphoma, Urothelial Carcinoma, Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carci
FDA approval history Drug class: anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors) Breastfeeding En español Patient resources Keytruda drug information Professional resources Keytruda prescribing information Pembrolizumab(AHFS Monograph) ...
“The approval of Keytruda for advanced hepatocellular carcinoma marks the second FDA approval for hepatocellular carcinoma in Merck’s oncology portfolio this year, underscoring our commitment to help bring forward new treatment options for cancers that have historically been very challenging to treat,”...
FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment...
The FDA approved this application nearly five months ahead of the PDUFA goal date of May 9, 2024. The approval is based on data from the Phase 3 KEYNOTE-A39 trial (also known as EV-302) in 886 patients with local...
Merck announced that the FDA granted full approval to KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as ...
Note:Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. SeeMedical Specialty Medication Quantity Limitsfor more information. Below includes dosing recommendations per the FDA-approved prescribing information for ...
WASHINGTON -- In an unprecedented move, the FDA today grantedaccelerated approvalopens in a new tab or windowto the cancer drug pembrolizumab (Keytruda) for treatment of any unresectable or metastatic solid tumor associated with the genetic abnormality known as microsatellite instability. ...
Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical can...