FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
Merck announced positive topline results from the pivotal phase III MK-3475A-D77 trial.
Addition of the immunotherapy drug pembrolizumab (Keytruda) to standard of care for patients with advanced soft tissue sarcoma of the limb significantly improved disease-free survival, according to the results of the SU2C-SARC032 clinical trial led by researchers from the University of Pittsburgh, UPMC, Duke University, and Princess Margaret Cancer Centre.
Promising preliminary results from an ongoing investigator-initiated phase I clinical trial evaluating the safety and efficacy of a combined regimen of Keytrua (pembrolizumab) and Lymphir (denileukin diftitox-cxdl or E7777) in patients with recurrent solid tumors were announced.
The European Commission has approved two new indications for Keytruda (pembrolizumab), an anti-PD-1 therapy, in gynecologic cancers.
The phase III KEYNOTE-689 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as a perioperative treatment for patients newly diagnosed with stage 3 or 4A, resected, locally advanced head and neck squamous cell carcinoma met its primary endpoint of event-free survival.
The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted positive opinions recommending approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, for two indications in gynecologic cancers.
Results from a large phase III clinical trial show that treatment with Keytruda (pembrolizumab) may nearly double the length of time people with high-risk muscle-invasive bladder cancer are cancer-free following surgical removal of the bladder.
