![]() These indications are approved under accelerated approval based on tumor response rate and durability of response continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. ![]() KEYTRUDA is indicated under accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established. KEYTRUDA is indicated under accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. KEYTRUDA is indicated under accelerated approval in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma. KEYTRUDA will continue to play an important role in the treatment of certain patients with gastric cancer: “Our research with KEYTRUDA has contributed to recent advances in the treatment of gastric cancer, and we are continuing to advance studies to help more patients with this disease.” Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “While there remains an unmet need for heavily pre-treated patients with advanced gastric cancer, we recognize that the treatment landscape has evolved and we respect the FDA’s efforts to continually evaluate accelerated approvals,” said Dr. This decision does not affect other indications for KEYTRUDA. Patients being treated with KEYTRUDA for metastatic gastric cancer in the third- or further-line setting should discuss their care with their health care provider. As agreed with the FDA, Merck will initiate the withdrawal in six months. The decision was made in consultation with the FDA following the April 29 Oncologic Drugs Advisory Committee evaluation of this third-line gastric cancer indication for KEYTRUDA as a monotherapy because it failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a Phase 3 study. Food and Drug Administration (FDA)-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 as determined by a U.S. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company plans to voluntarily withdraw the U.S.
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