The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval makes Keytruda available for patients with PD-L1-positive tumors as determined by an FDA-approved test and who progressed following two or more lines of treatment, including fluoropyrimidine and platinum-based chemotherapy. If appropriate, patients must also have received HER2-targeted therapy.
The accelerated approval was supported by positive tumor response rates and durability of responses seen in the Phase 2 KEYNOTE-059 trial (NCT02335411). Continued approval is dependent on confirmatory trials that further demonstrate Keytruda’s benefit for these gastric cancer patients.
“Historically, advanced gastric cancer has been particularly challenging to treat, and new treatment options are needed for these patients,” Charles S. Fuchs, MD, MPH, lead investigator and director of Yale Cancer Center, said in a press release. “The results observed in the diverse population of heavily pretreated advanced gastric or GEJ patients from the KEYNOTE-059 clinical trial demonstrate that pembrolizumab in the third-line setting has the potential to shift how we care for certain patients facing this difficult-to-treat disease.”
Source: Immuno-Oncology News
