CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients, announces receipt of a letter from the Center for Drug Evaluation (CDE) (group within the China FDA in charge of technical review) indicating that EVOMELA® (melphalan) for injection has been scheduled for review by the Expert Advisory Anti-Tumor (Oncology) Drugs Committee (the "Advisory Committee"), which is scheduled to take place between April 25-26, 2018 (the "Advisory Committee Meeting").
The Advisory Committee Meeting is a closed meeting. No additional information on the EVOMELA®application has been requested by the CDE in advance of the Advisory Committee Meeting, however, CASI will submit a Clinical Data Briefing Package which will summarize the various components contained in the previously submitted application.
EVOMELA® was accepted under CFDA's new guidelines for priority review and the review by the Advisory Committee was expected as part of the recently implemented CFDA reforms. CASI anticipates that after the Advisory Committee Meeting, the Advisory Committee will make a recommendation to CDE, followed by CDE recommendation to CFDA, and CFDA notification of review status to CASI.
As reported previously, the September 2017 CFDA letter provided the following reasons for granting priority review of EVOMELA®:
- EVOMELA®is indicated for the treatment of multiple myeloma, which is classified as a rare disease in China;
- There is no melphalan in any formulation available in China to address this unmet medical need;
- EVOMELA® has clear therapeutic advantage to currently available therapeutics.
Wei-Wu He, Ph.D., CASI Pharmaceuticals Executive Chairman, commented, "Receiving notice from CDE regarding the Advisory Committee Meeting is very exciting news. This indicates the completion of the CDE's initial review of the EVOMELA® NDA package and referral to the panel of independent experts is the next step in the review process. Multiple myeloma is the second most common hematological malignancy which often occurs in elderly patients. The Advisory Committee review of the EVOMELA® application marks a significant milestone toward addressing an unmet medical need for patients with multiple myeloma in China, as there are no versions of melphalan commercially available. EVOMELA®'s innovative and proprietary new formulation of melphalan offers significant advantages in that it does not contain propylene glycol which causes significant side effects, has long stability and is the only intravenous melphalan product approved for use in the high-dose conditioning indication in pre-transplant therapy".
About CASI Pharmaceuticals, Inc.
CASI is a U.S. based biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients. CASI's product pipeline features (1) EVOMELA®, MARQIBO®, and ZEVALIN®, all U.S. Food and Drug Administration (FDA) approved drugs in-licensed from Spectrum Pharmaceuticals, Inc. for China regional rights, and currently in various stages in the regulatory process for market approval in China, (2) an acquired portfolio of 25 FDA-approved abbreviated new drug applications (ANDAs), one ANDA that was tentatively approved and three ANDAs that are pending FDA approval, from which CASI will prioritize a select subset for product registration and commercialization in China, (3) our proprietary drug candidate, ENMD-2076, currently in Phase 2 clinical development, and (4) proprietary early-stage candidates in immuno-oncology preclinical development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com and in the Company's filings with the U.S. Securities and Exchange Commission.
