FDA Approves First-Line Pembrolizumab: Metastatic MSI-High/dMMR Colorectal Cancer

Patients with unresectable or metastatic colorectal cancer with high microsatellite instability (MSI) or a deficiency in mismatch repair (dMMR) now have their first frontline immunotherapy option, thanks to the FDA's approval of pembrolizumab (Keytruda®, Merck) in this population. Efficacy and safety were investigated in an open-label phase 3 trial, KEYNOTE-177 (NCT02563002), for which 307 patients with previously untreated MSI-high/dMMR metastatic colorectal cancer and an Eastern Cooperative On...
Continue reading

FDA Approves Pembrolizumab for Cutaneous Squamous Cell Carcinoma

For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC), pembrolizumab (Keytruda®, Merck & Co., Inc.) is now FDA approved. An immunotherapy originally approved for advanced non-small cell lung cancer, melanoma, high-risk non-muscle invasive bladder cancer, and advanced cervical cancer, among others, pembrolizumab targets the programmed death (PD-1) pathway to prevent cancer cells from hiding. This allows the body's T cells to attack and kill cancer cells. Approval ...
Continue reading

Pembrolizumab Approved: Solid Tumors With High Tumor Mutational Burden

The FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for adults and children with previously treated unresectable or metastatic tumor mutational burden (TMB)–high solid tumors, defined as tumors with at least 10 mutations per megabase, who have no satisfactory alternative treatment option. The FDA also approved the FoundationOne® CDx assay (Foundation Medicine) as the companion diagnostic used to determine treatment eligibility. The approval was based on data from a prospecti...
Continue reading

Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma: John Kuruvilla, MD

This past weekend in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, John Kuruvilla, MD, presented results of the phase 3 KEYNOTE-204 trial, reporting that pembrolizumab significantly increased progression-free survival compared with brentuximab vedotin in patients with relapsed/refractory classic Hodgkin lymphoma. In this interview with i3 Health, Dr. Kuruvilla, an Associate Professor of Medicine at the University of Toronto, discusses the challenges of treatin...
Continue reading

New Dosing Guidelines for Pembrolizumab FDA Approved

The FDA recently approved new dosing guidelines of 400 mg of pembrolizumab (KEYTRUDA®, Merck) to be taken every six weeks. The current recommended dose of pembrolizumab is 200 mg every three weeks. This new dosing regimen is approved across all adult indications of pembrolizumab. Pembrolizumab is FDA approved to treat several cancers including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-...
Continue reading

Copyright © 2020 i3 Health. All rights reserved.