FDA Approves Keytruda for Cancers with Specific Biomarker
On May 23, 2017, FDA approved Merck’s blockbuster cancer drug Keytruda (pembrolizumab) for the treatment of cancers with a specific biomarker. This new approval marks the first-time FDA has approved a treatment based on a common biomarker, as opposed to the location in the body where the tumor originated.
“This is an important first for the cancer community,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “Until now, the FDA has approved cancer treatments based on where in the body the cancer started-for example, lung or breast cancers. We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”
In clinical trials, of the 149 patients who received the drug, 39.6% had a complete or partial response. For 78% of these patients, the response lasted for six months or more, FDA wrote.
Keytruda is approved for other indications including melanoma and non-small cell lung cancer, among others. The drug was listed as a topic selling drug in Merck’s 2016 full-year financial results.
FDA Approves Opdivo Plus Yervoy Regimen for MSI-H/dMMR Colorectal Cancer
April 9th 2025Approval of the Opdivo plus Yervoy combination regimen was based on results from the Phase III CheckMate-8HW trial, which was the largest immunotherapy study in patients with previously untreated, unresectable, or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
Navigating Distrust: Pharma in the Age of Social Media
February 18th 2025Ian Baer, Founder and CEO of Sooth, discusses how the growing distrust in social media will impact industry marketing strategies and the relationships between pharmaceutical companies and the patients they aim to serve. He also explains dark social, how to combat misinformation, closing the trust gap, and more.
