Rivoceranib was designated as an orphan drug designation for liver cancer by the FDA on the 4th of November.
The orphan drug designation is a system that supports the smooth development and approval of treatments for rare and intractable diseases. If designated as an orphan drug, new drug developers will be able to enjoy a variety of benefits, including approval of clinical trials and shortened clinical trial permits, exemption of specialty drug license user fee, tax cuts, and the exclusive market rights for seven years after obtaining permits.
HLB is undergoing phase 3 global clinical trials for liver cancer (primary) as a combination therapy of Rivoceranib and Camrelizumab. As Rivoceranib is designated as an orphan drug following Camrelizumab (liver cancer, this April), a significant reduction is expected in the licensing period in the future.
The phase 3 clinical trial for liver cancer (primary) of Rivoceranib is underway by comparing Overall Survival (OS) and Progressive-free Survival (PFS) as the primary evaluation indicators, and is underway in the United States, South Korea, Europe, China, and Taiwan. A total of 510 patients have been recruited, and clinical trials are underway in 10 locations in Korea, including Asan Medical Center, Samsung Medical Center, and Seoul National University Hospital.
Rivoceranib is an oral anticancer substance that inhibits VEGFR-2, inhibits the production of new blood vessels, normalizes blood vessels, and activates immune cells. With this mechanism, it has good versatility and fewer side effects along with other types of anticancer drugs such as cytotoxic anticancer drugs and immuno-cancer drugs. In fact, Camrelizumab and Rivoceranib were both approved as secondary treatments for liver cancer in March and December last year, respectively, and Rivoceranib's clinical results were also published in the renowned medical journal 'Lancet', raising expectations for the efficacy of the combination of the two drugs.
The following anti-cancer drug was designated as an orphan drug for gastric cancer by the FDA in June 2017 and was also designated for Adenoid Cystic Carcinoma (ACC) in February this year.
In addition to liver cancer, HLB is preparing New Drug Application (NDA) as a treatment for end-stage gastric cancer and is simultaneously undergoing phase 2 ACC (primary), phase 2 gastric cancer (primary), and phase 1b/2 colon cancer (third). The recruitment of ACC clinical patients has been completed in both United States and South Korea.