National Medical Products Administration Approves Melphalan Hydrochloride For Injection (EVOMELA®, formulation based on SBECD aka. Captisol or Dexolve) as Treatment for Specific Uses in Patients with Multiple Myeloma
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in China and throughout the world, announced that it has received National Medical Products Administration (“NMPA”) (formerly, the China FDA) approval of Melphalan Hydrochloride For Injection (EVOMELA®), for:
- use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and
- the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
The NMPA approved Melphalan Hydrochloride For Injection (EVOMELA®) under its new priority review guidelines. The NMPA’s Expert Advisory Anti-Tumor (Oncology) Drugs Committee previously had reviewed Melphalan Hydrochloride For Injection (EVOMELA®) in April, 2018. The NMPA approval of Melphalan Hydrochloride For Injection (EVOMELA®) Melphalan Hydrochloride For Injection (EVOMELA®) for use in patients with multiple myeloma was based on an existing safety and efficacy data base; the NMPA required no additional pre-approval clinical studies, but requires a post approval confirmatory study.
CASI Pharmaceuticals Executive Chairman Wei-Wu He, Ph.D., commented, “NMPA approval of Melphalan Hydrochloride For Injection (EVOMELA®) is encouraging news for patients in China with multiple myeloma as there is no commercially available melphalan formulation in the country. EVOMELA’s approval therefore addresses a significant unmet medical need. In addition, EVOMELA®‘s proprietary formulation of melphalan, a first-line therapy for multiple myeloma patients, offers considerable clinical advantages as it does not contain propylene glycol, which may cause side effects, it has long stability when reconstituted for infusion, and is the only intravenous melphalan product approved for use in the high-dose conditioning indication in pre-transplant therapy.”
Dr. He continued, “CASI will continue to rapidly build out its commercial operations and we are working to launch Melphalan Hydrochloride For Injection (EVOMELA®) in China promptly to meet the needs of patients suffering from this devastating disease. With the approval of Melphalan Hydrochloride For Injection (EVOMELA®), CASI becomes an integrated commercial-stage company; we will continue working tirelessly to address varying unmet medical needs within China and throughout the world..”