Merck's Keytruda is now approved for over 20 indications

Posted on August 01, 2019 by Medtech[y] Staff

Earlier this week, Merck ($MRK) announced that the FDA approved KEYTRUDA as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

The approval brings the total approved indications for Merck's checkpoint inhibitor to 21, with over 1,000 ongoing clinical trials for a variety of cancers and treatment settings.

“Historically, patients with advanced esophageal cancer have had limited treatment options, particularly after their disease has progressed,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “With this approval, KEYTRUDA is now the first anti-PD-1 therapy approved for the treatment of previously-treated patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10), providing an important new monotherapy option for physicians and patients in the United States.”

The approval was based on data from KEYNOTE-181 (NCT02564263), a multicenter, randomized, open-label, active-controlled trial that enrolled 628 patients with recurrent locally advanced or metastatic esophageal cancer who progressed on or after one prior line of systemic treatment for advanced disease. Patients with HER2/neu positive esophageal cancer were required to have received treatment with approved HER2/neu targeted therapy. All patients were required to have tumor specimens for PD-L1 testing at a central laboratory; PD-L1 status was determined using the PD-L1 IHC 22C3 pharmDx kit. Patients with a history of non-infectious pneumonitis that required steroids or current pneumonitis, active autoimmune disease, or a medical condition that required immunosuppression were ineligible.

Are you a recruiter or company looking to fill a Medical Sales opening, including the medical device or biotech industries? If so, checkout Medtechy Jobs and create a free employer account or a free candidate account. All of our jobs are strategically distributed to our diverse following of experienced and those new to the industry. Multi-pack jobs start at $100.

We are also excited to launch Medtechy Deals, our new store which sources deals on gadgets, everyday carry essentials and online courses for employees in the healthcare industry!

Please follow us on Facebook, Twitter, and LinkedIn for the latest medical technology news, medical device/biotech company intel and career opportunities. You can also sign up for our monthly newsletter.