US FDA Nods Keytruda Plus Gemcitabine & Cisplatin To treat patients

Merck announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck's anti-PD-1 therapy in combination with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). The approval was based on results from the phase 3 KEYNOTE-966 trial, in which Keytruda plus chemotherapy demonstrated a statistically significant improvement in the study’s primary endpoint of overall survival (OS), reducing the risk of death by 17% (HR=0.83 [95% CI, 0.72-0.95]; one-sided p=0.0034) compared to chemotherapy alone at the trial’s pre-specified final analysis for OS. Median OS was 12.7 months (95% CI, 11.5-13.6) for Keytruda plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone.

This approval marks the sixth indication for Keytruda in gastrointestinal cancers, as per pharmabiz. Immune-mediated adverse responses can occur in any organ system or tissue and can impact more than one bodily system at the same time. Immune-mediated adverse events, such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic responses, solid organ transplant rejection, and problems of allogeneic hematopoietic stem cell transplantation, can develop at any point during or after Keytruda treatment. The list of significant immune-mediated adverse responses shown here may not contain all potentially severe and deadly immune-mediated adverse events. To ensure the safe administration of Keytruda, it is critical to detect and manage immune-mediated adverse effects as soon as possible. Keytruda should be withheld or totally discontinued based on the severity of the adverse response, and corticosteroids should be supplied if necessary. Infusion-related responses to Keytruda might sometimes be serious or life-threatening. When delivered to a pregnant woman, Keytruda has the potential to cause fetal damage due to its method of action.