Merck has revealved that the Phase 3 Keynote-181 trial investigating Keytruda, Merck’s anti-PD-1 therapy, as monotherapy in the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma has met a primary endpoint of overall survival (OS) in patients whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10). In this pivotal study, treatment with Keytruda resulted…
Merck’s HIV Therapy Delstrigo Meets Primary Efficacy Endpoint in Phase 3 Study
Merck presented data from the Phase 3 DRIVE-SHIFT trial evaluating a switch of medication to Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg), in adults with HIV-1 infection who demonstrated virological suppression for at least six months on a stable antiretroviral treatment regimen.…
FDA Grants Priority Review to Merck’s Application for New Keytruda Indication
Ther FDA has accepted Merck’s application for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1…
Keytruda Is The First Anti-PD-1 Therapy Approved In China For Advanced Melanoma
Keytruda, Merck’s anti-PD-1 therapy, has been approved by the China National Drug Administration (CNDA) for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy. This is the first and only approval of an anti-PD-1 therapy for advanced melanoma in China. “Over the past decades, we have…
FDA Grants Priority Review To Merck’s Keytruda In Combination With Chemotherapy
Merck announced that the FDA has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. This sBLA, which is seeking accelerated approval for this new indication, is based on…
AstraZeneca And Merck’s Lynparza Delays Ovarian Cancer Progression
AstraZeneca and Merck announced positive results from the randomized, double-blinded, placebo-controlled, Phase 3 SOLO-1 trial of Lynparza (olaparib) tablets. Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated first-line with Lynparza maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo. The safety and tolerability profile of Lynparza was consistent with previous trials.…
FDA Approves Merck’s Keytruda For Metastatic Cervical Cancer
The FDA has approved Merck’s Keytruda, the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. This indication is approved under the FDA’s accelerated approval regulations based on…
Merck’s Keytruda Plus Chemotherapy Significantly Improved Overall Survival In Study
Merck announced results from Keynote-407, a pivotal, Phase 3 study evaluating Keytruda , Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC). In this study, the Keytruda plus chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone.…
Keytruda Demonstrates Improved Survival Benefit In Advanced NSCLC
Merck, known as MSD outside the United States and Canada, announced that the pivotal Phase 3 KEYNOTE-407 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC), met the dual primary endpoints of overall survival and progression-free survival. Based on an interim analysis conducted…
FDA Grants Priority Review to Immunotherapy Combination with Chemotherapy as First-Line Treatment for Lung Cancer
EMA Accepts Regulatory Submission for LYNPARZA (olaparib)
Anticancer Agent LENVIMA (lenvatinib mesylate) Approved for Additional Indication of Unresectable Hepatocellular Carcinoma
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) for Treatment of Advanced Cervical Cancer
Ferring Pharmaceuticals, Merck Complete Largest Clinical Trial Ever in Postpartum Hemorrhage
Selumetinib Granted Orphan Drug Designation by FDA for Neurofibromatosis Type 1
Football Hall of Famer and Cancer Survivor Jim Kelly Joins Merck to Challenge America to Raise Funds for the Cancer Community
Merck’s Keytruda Meets Survival Endpoints In Pivotal Lung Cancer Study
Merck’s Keytruda (pembrolizumab) significantly improved overall survival and progression-free survival as first-line treatment in combination with pemetrexed and platinum chemotherapy for patients with metastatic non-squamous non-small cell lung cancer (KEYNOTE-189). Merck, known as MSD outside the United States and Canada, announced that the pivotal Phase 3 KEYNOTE-189 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in…
LENVIMA, KEYTRUDA Receive Breakthrough Therapy Designation as Combo Therapy for RCC
Eisai Co., Ltd. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the potential treatment of patients with advanced and/or…
Merck to Acquire Rigontec to Further Immuno-Oncology Efforts
Merck to acquire Rigontec, RIG-I therapeutics pioneer, advancing leadership in immuno-oncology. Merck, known as MSD outside the United States and Canada, and Rigontec announced that Merck will acquire Rigontec. Rigontec is a pioneer in accessing the retinoic acid-inducible gene I (RIG-I) pathway, part of the innate immune system, as a novel and distinct approach in cancer…
FDA Grants Tentative Approval to Merck’s Follow-On Biologic Basal Insulin
Merck, known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA™ Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed by Merck with funding from Samsung Bioepis. With the…
Merck & Pfizer Announce Ertugliflozin Met Primary Endpoint in Two Phase 3 Studies
Merck Enters Licensing Agreement for Teijin Pharma’s Alzheimer’s Candidate
Merck’s Keytruda Gains FDA Approval as First-Line Combination Therapy for NSCLC
FDA Approves Merck’s Keytruda for Adult and Pediatric Patients
FDA Accepts Two sBLAs for Merck’s Keytruda Bladder Cancer Treatment
FDA accepts two sBLAs for Merck’s Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings. Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for Keytruda…