Phase 3 Clinical Trials Underway
HLB announced on Nov. 8 that its oral cancer drug candidate "Rivoceranib" has been designated as an orphan drug for liver cancer treatment by the U.S. Food and Drug Administration (FDA) on Nov. 4.
The FDA operates the Orphan Drug Designation (ODD) program to support the development of orphan drugs.
Orphan drug designation awardees are granted the following benefits from the FDA: Tax credits of 50 percent off the clinical drug testing cost awarded upon approval; eligibility for market exclusivity for seven years post approval; waiver of new drug application (NDA)/ biologics license application (BLA) application fee (approximately US$2.2 million value).
HLB is conducting Phase 3 global clinical trials to confirm the effectiveness for liver cancer of coadministration of Rivoceranib and Camrelizumab, an anticancer drug of Jiangsu Hengrui Medicine of China. The trials are in progress in Korea, the United States, Europe, China, and Taiwan with 510 patients. In Korea, it will be held at 10 hospitals, including the Asan Medical Center in Seoul, Samsung Medical Center and Seoul National University Hospital.