23 May 2017 - Keytruda now approved for patients with MSI-H or mismatch repair deficient solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options, which includes MSI-H or mismatch repair deficient colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Merck today announced that the U.S. FDA has approved a new indication for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy. Keytruda is now indicated for the treatment of adult and paediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient:

• solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
  
• colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
  

This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Read Merck press release