China FDA Prepares to Review Evomela for Approval in Multiple Myeloma Treatment
Multiple myeloma patients in China may soon have access to an injectable formulation of melphalan, called Evomela, as the China Food and Drug Administration (CFDA) prepares to review CASI Pharmaceutical‘s application requesting its approval.
If approved, the therapy will be the only melphalan formulation available for myeloma patients in China.
The CFDA’s Expert Advisory Anti-Tumor (Oncology) Drugs Committee, a committee responsible for reviewing cancer treatments, is scheduled to meet April 25-26. CASI anticipates a positive recommendation to the Center for Drug Evaluation (CDE), followed by a CDE recommendation to the CFDA for Evomela’s approval.
“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,” Wei-Wu He, PhD, executive chairman of CASI Pharmaceuticals, said in a press release.
The therapy will be reviewed under the CFDA’s priority review status, which was granted to Evomela in September 2017. The CFDA cited the following reasons in giving the therapy priority review: Evomela is indicated for multiple myeloma, which is classified as a rare disease in China; there is no other formulation of melphalan available in China; and Evomela is an advantageous therapeutic option over other available treatments for multiple myeloma.
“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,” He said.
Although neither the CDE nor the advisory committee requested additional information other than what was included in the initial application, CASI will submit a clinical data briefing package summarizing the various components of Evomela’s application.
Evomela has been commercially available in the United States since 2016 by Spectrum Pharmaceuticals. It was approved by the U.S. Food and Drug Administration as a high-dose conditioning treatment for patients preparing for a stem cell transplant. It is also indicated as palliative treatment of patients with multiple myeloma who cannot receive oral therapy.