CASI Pharmaceuticals’ Import Drug Registration Application For EVOMELA® Accepted For Review By CFDA
ROCKVILLE, Md., Dec. 5, 2016 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announced today that China’s Food and Drug Administration (CFDA) has accepted for review the Company’s import drug registration application for EVOMELA® (melphalan) for Injection.
CASI’s China rights to EVOMELA (melphalan) for Injection was previously licensed from its partner Spectrum Pharmaceuticals, Inc. along with two other commercial-stage Spectrum drugs, MARQIBO® and ZEVALIN®. EVOMELA received U.S. FDA approval earlier this year for multiple myeloma patients as a high-dose conditioning treatment prior to autologous stem cell transplantation (ASCT) and as palliative treatment for patients who are not candidates for oral therapy. It was launched in the U.S. this year by Spectrum.
Ken Ren, Ph.D, CASI’s Chief Executive Officer, commented, “Multiple myeloma is the second most common malignancy in blood cancers, often occurring in elderly patients. There were more than 12,000 new cases and more than 9,000 deaths from multiple myeloma in China in 2015. With the aging of China’s population, the number of new cases is rapidly rising. Melphalan is extensively used worldwide in the treatment of multiple myeloma and is the main drug in pre-transplant conditioning therapy. Melphalan, however, is not currently commercially available in China. EVOMELA, an innovative and proprietary new formulation of melphalan, offers significant advantage in that it (i) does not contain propylene glycol which causes significant side effects; (ii) has longer stability; and (iii) is the only intravenous melphalan product approved for use in the high-dose conditioning indication. We look forward to working with the CFDA to advance EVOMELA towards market approval.”
