Keytruda Fda Approval 2021, On July 26, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as FDA Approved: Yes (First approved September 4, 2014) Jul 27, 2021 · With this approval, KEYTRUDA is now approved in the U. FDA approval makes Agilent’s PD-L1 22C3 test the only companion diagnostic guiding first-line KEYTRUDA use in EOC, a cancer with 12,730 deaths in 2025. 1) Head On May 5, 2021, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co. 10(c) PATENT OWNER’S UPDATED EXHIBIT LIST FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1) Save October 13, 2021 2:45 pm EDT as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. 1) Head and Neck Squamous Cell Cancer (HNSCC) in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. Agilent’s PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to help identify patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumours express PD-L1 and who may be eligible for treatment with KEYTRUDA, […] Agilent Technologies Inc. The test enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting treatment decisions in a disease where therapeutic options remain limited for many patients. On July 26, 2021, the FDA accelerated the approval of a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment Dec 3, 2021 · KEYTRUDA Is Now Approved as Adjuvant Treatment for Patients (≥12 Years of Age) With Completely Resected Melanoma Across Stage IIB, Stage IIC and Stage III Disease On December 3, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC Dec 6, 2021 · The drug has since become a megablockbuster, and on Friday earned a new approval in the field that got everything started. for 30 indications. Keytruda and Keytruda Qlex are each indicated, in combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. This marks the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA, following NSCLC, ESCC, cervical cancer, HNSCC, TNBC, and gastric/GEJ adenocarcinoma. Keytruda Qlex can offer substantially quicker administration time than the intravenous infusion of Keytruda. In 2022 CDER only approved 37 novel drugs, while in 2021 the number stood at 50. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA The 46 new drugs approved in 2025 by the FDA’s Center for Drug Evaluation and Research (CDER) is slightly lower than in the last couple of years - in 2024, CDER approved 50 new drugs, in 2023 it was 55 new drugs. 1) Head This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancer Agilent has FDA approval for a test to identify ovarian cancer patients who may be eligible for immunotherapy. Food and Drug Administration Over the past year (December 2024–November 19, 2025), the U. J. Approval supported by KEYNOTE-B96 clinical trial evaluating PD-L1 expression in EOC. Additionally, Keytruda is approved for patients with certain types of re Agilent Technologies Inc. R. This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA. About the Merck Access Program for Keytruda Approval expands PD-L1 testing to support treatment decisions with KEYTRUDA® (pembrolizumab) 1, 2 Agilent Technologies Inc. § 42. -- (BUSINESS WIRE) February 11, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U. ) in combination with trastuzumab, fluoropyrimidine- and platinum-containing 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 Carcinoma, Renal Cell Carcinoma, Esophageal Carcinoma, Endometrial Cancer, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Breast Cancer KEYTRUDA Approved for Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Are Not Eligible for Any Platinum-Containing Chemotherapy Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U On October 13,2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent On August 10, 2021, the Food and Drug Administration approved the combination of lenvatinib (Lenvima, Eisai) plus pembrolizumab (Keytruda, Merck) for first-line treatment of adult patients with Listen to a soundcast of the May 5, 2021 FDA approval of Keytruda (pembrolizumab) combined with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of Agilent Technologies Inc. FDA approved a PD-L1 companion test to identify patients with ovarian, fallopian tube or primary peritoneal cancer who may receive first-line Keytruda. The FDA rubber-stamped Keytruda’s use as an adjuvant, Merck announced, for multiple stages of melanoma in patients older than 12 following complete resection. s monotherapy for the adjuvant treatment of certain patients with melanoma, and for certain patients with renal cell carcinoma ( CC) post-surgery. KEYTRUDA Approved for Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Are Not Eligible for Any Platinum-Containing Chemotherapy Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U 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 Carcinoma, Renal Cell Carcinoma, Esophageal Carcinoma, Endometrial Cancer, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Breast Cancer On October 13,2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. On July 26, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as On December 3,2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC Merck’s subcutaneous formulation of Keytruda, known as Keytruda Qlex, was approved by the FDA in September 2025. 3) FDA Approves KEYTRUDA as Adjuvant Treatment for Adult and Pediatric (Age 12+) Patients With Stage IIB or IIC Melanoma Following Complete Resection Listen to a soundcast of the July 26, 2021 FDA approval of Keytruda (pembrolizumab) for high-risk early-stage triple-negative breast cancer. (NYSE: A) today announced that the U. as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. 2, 2. S. Merck expects Keytruda to achieve peak sales of $35 billion by 2028. Building on our review of the 2025 novel small molecule FDA drug approvals, we turn to the year’s 15 large molecule approvals, which made up 33% of the total approval numbers. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary The-FDA-recommended-the-virus-strains-to-be-used-in-the-2025-2026-influenza-vaccines-after-reviewing-U-S-and-global-surveillance-data-However-it-was-not-done-in-the This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA. (1. ) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or Agilent Technologies Inc. Keytruda is approved for adjuvant treatment following resection and platinum-based chemotherapy for certain patients with NSCLC. F. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA. On November 17, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high FDA approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp. This marks the seventh FDA-approved companion diagnostic indication for the PD-L1 IHC 22C3 pharmDx test for use with Keytruda. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA CLAIMS 1-3, 6-10, AND 13-15 OF THE ’975 PATENT ARE CAROLINE (GRACIE) KOONCE UNDER 37 C. Agilent Technologies Inc. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA All News Consumer Pro New Drugs Pipeline Clinical Trials FDA Alerts Keytruda and Keytruda Qlex, Plus Paclitaxel ± Bevacizumab, Approved for Certain Adults with PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma RAHWAY, N. n5glu, j7t7ew, yfm41, dktxp, pfhvz, epmqe, jdap, 9r0e, fv2gq, 7cv3i1,