EMA Grants Priority Medicine Status to Cellectar’s Waldenstrom Macroglobulinemia Treatment
FLORHAM PARK, N.J., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to iopofosine I 131, the company’s lead small-molecule drug candidate, for Waldenstrom’s macroglobulinemia (WM) in patients who have received two or more prior treatment regimens.
The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. These medicines are considered priority medicines by the EMA and are intended to reach patients earlier. To be accepted for PRIME, new therapies must demonstrate the potential to significantly address an unmet medical need in clinical trials.
“PRIME designation from the EMA further underscores our confidence in iopofosine I 131 to provide a differentiated and highly needed new treatment option for patients with WM,” said James Caruso, president and CEO of Cellectar. “We expect to release top-line data from the CLOVER-WaM pivotal trial in the fourth quarter of 2023 and submit our NDA in March, 2024. With PRIME designation now in hand we look forward to advancing our EU strategy to bring this potential targeted treatment option to patients in the US and EU as quickly as possible.”
The U.S. Food and Drug Administration (FDA) has granted Cellectar’s lead asset iopofosine I 131, a small-molecule Phospholipid Drug Conjugate™ (PDC) designed to provide targeted delivery of iodine-131 (radioisotope), Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as relapsed (or refractory) multiple myeloma and relapsed (or refractory) diffuse large B-cell lymphoma (DLBCL). The company expects to complete our ongoing Phase 2b WM pivotal trial (NCT02952508) in the second half of 2023 and assuming an FDA Priority Review and approval, remains on target for a 2024 US product launch.
Source: Cellectar Biosciences
