The Food and Drug Administration has accepted a new supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda; Merck), 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).
The Agency has granted the application priority review . It is based on data from the phase 3 ‘KEYNOTE-590’ trial, which evaluated pembrolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with esophageal and GEJ cancer. A total of 749 individuals were randomized to receive either:
- Pembrolizumab (200mg IV on Day 1 of each 3-week cycle for up to 35 cycles); plus cisplatin (80mg/m2 IV on Day 1 of each 3-week cycle for up to 6 cycles); plus 5-FU (800mg/m2 IV per day on Day 1 to Day 5 of each 3-week cycle, or per local standard for 5-FU administration, for up to 35 cycles); or
- Placebo; plus cisplatin (80mg/m2 IV on Day 1 of each 3-week cycle for up to 6 cycles); plus 5-FU (800mg/m2 IV per day on Day 1 to Day 5 of each 3-week cycle, or per local standard for 5-FU administration, for up to 35 cycles).
Results presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 showed significant improvements in the primary endpoints of overall survival and progression-free survival for the pembrolizumab group vs chemotherapy, regardless of PD-L1 expression status and tumor histology.
The FDA has set a Prescription Drug User Fee Act date of April 13, 2021 to make a decision on this sBLA.
Dr Vicki Goodman, vice president, clinical research, Merck Research Laboratories said, “We look forward to working with the FDA to bring a new option to patients in the first-line setting.”
Pembrolizumab is marketed under the brand name Keytruda and is currently approved in the US as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1.
For more information visit merck.com.
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Esophageal and Gastroesophageal Junction Cancer. [press release] Kenilworth, NJ: Merck; December 17, 2020.