Posted by Michael Wonder on 23 Sep 2021
Innovent announces NMPA acceptance of a supplemental new drug application for sintilimab in combination with chemotherapy as first-line therapy for oesophageal squamous cell carcinoma
22 September 2021 - Innovent Biologics today announced that the National Medical Products Administration of China has accepted the supplemental new drug application for sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) for the first-line treatment of oesophageal squamous cell carcinoma.
The supplemental new drug application application is based on the interim analysis of the global randomised, double-blind, multi-centre Phase 3 ORIENT-15 clinical trial – which evaluated sintilimab in combination with chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for oesophageal squamous cell carcinoma.
