Celltrion Submits Amendment for Phase 3 Trial of Cancer Biosimilar to US FDA
MT Newswires Live
Jul 07
Celltrion (KRX:068270) submitted an investigational new drug (IND) amendment for a global Phase 3 trial of CT-P51, the biosimilar of its cancer drug Keytruda, to the U.S. Food & Drug Administration, according to a Monday filing with the Korea Exchange.
The randomized, double-blind, active-controlled clinical trial will enroll 220 previously untreated patients who have metastatic non-squamous non-small cell lung cancer to compare the efficacy and safety of CT-P51 against the reference drug over a two-year treatment period, the filing said.
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