This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2020
  • /
  • 12
  • /
  • Keytruda + chemotherapy filed at FDA supplemental ...

Keytruda + chemotherapy filed at FDA supplemental sBLA as first-line treatment for locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer.

Read time: 1 mins
Published:24th Dec 2020
Merck Inc., has announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ). This sBLA is based on data from the pivotal Phase III KEYNOTE-590 trial, in which Keytruda plus chemotherapy demonstrated significant improvements in the primary endpoints – overall survival (OS) and progression-free survival (PFS) – versus chemotherapy in these patients regardless of PD-L1 expression status and tumor histology. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 13, 2021.
Condition: Oesophageal Cancer
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.