On November 11, 2021 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the U.S. Food and Drug Administration (FDA) has granted rivoceranib with orphan drug designation for the treatment of hepatocellular carcinoma (HCC) (Press release, Elevar Therapeutics, NOV 11, 2021, View Source [SID1234595245]). HCC is the most common primary liver malignancy and is a leading cause of cancer-related death worldwide.
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"The orphan drug designation granted by the FDA recognizes the potential of rivoceranib to address the urgent unmet need for new therapies that can improve patient outcomes for people with HCC," said Kate McKinley, Chief Executive Officer of Elevar Therapeutics. "The medical community is eager to see the results of clinical trials exploring new combination regimens in HCC and we look forward to rapidly advancing our clinical trial of rivoceranib and camrelizumab, an investigational PD-L1 inhibitor. This Phase 3 trial is being conducted in collaboration with Jiangsu Hengrui Medicine Company, Ltd., in patients with advanced HCC who have not received prior systemic therapy. In addition to our HCC program, we are committed to accelerating the clinical development for rivoceranib as a potential therapy for the treatment of gastric cancer, adenoid cystic carcinoma, and colorectal cancer."
HCC is a highly lethal form of liver cancer with limited treatment options, which is primarily caused by chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV), nonalcoholic steatohepatitis (NASH), and excessive alcohol consumption.
"Unfortunately, HCC is often diagnosed at later stages of disease and there are limited treatment options currently available," said Maureen G. Conlan, M.D., F.A.C.P., Chief Medical Officer of Elevar Therapeutics. "We are encouraged by the progress that we are making in our Phase 3 clinical trial and believe that the combination of rivoceranib and camrelizumab, if approved, will offer an important new therapeutic option for clinicians and patients."
The FDA’s Office of Orphan Drug Products grants orphan status to medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user filing fees and potential eligibility for seven years of marketing exclusivity post-approval.
About Rivoceranib (apatinib)
Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer, under the name apatinib, in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Apatinib has been studied in over 1,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy.
Clinical studies are underway in multiple tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (combination with camrelizumab), adenoid cystic carcinoma, and colorectal cancer (combination with Lonsurf). Orphan Drug designations have been granted in gastric cancer (U.S., EU, and South Korea), adenoid cystic carcinoma (U.S.) and hepatocellular carcinoma (U.S.). Elevar Therapeutics holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Apatinib is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Medicine Co., Ltd under the brand name Aitan.