Cellectar Biosciences Inc. (NASDAQ:CLRB) announced that the FDA has given Fast Track designation for CLR 131 in the treatment of Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL) patients that have received previous treatment regimens.
CLR 131 demonstrated 100% Overall Response Rate in treatment of LPL/WM
CLR 131 is Cellectar’s small-molecule, cancer-targeting therapeutic Phospholipid Drug Conjugate. It has been designed to offer cytotoxic radiation selectively and directly to cancer stem cells and cancer cells. The company is currently evaluating CLR 131 in the second phase CLOVER-1 clinical trial in patients with refractory/relapsed multiple myeloma and Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma.
James Caruso, the CEO and President of Cellectar indicated that WM/LPL patients that are intolerant or don’t respond optimally to ibrutinib have few treatment options, and their survival rates are poor. Therefore the Fast Track designation will support the company’s clinical development strategy for quick and efficient effective therapy for such patients.
The CEO added that all the four WM/LPL patients that have been treated in the second phase CLOVER-1 trial have attained 100% ORR as well as a complete response rate of 25%. As a result, the strong response rate represents a significant improvement in the treatment of refractory or relapsed LPL/WMM. So far, there is no late-stage development or approved treatment for refractory or relapsed patients who have shown complete responses.
Cellectar received Orphan Drug Designation for CLR 131 early this year
At the beginning of this year, the company announced that it had been granted Orphan Drug Designation for CLR 131 in LPL. Besides the wide range of benefits the company can derive from the ODD, it will also receive enhanced engagement and support from the FDA, supporting the regulatory approval pathway for WM/LPL.
The Fast Track Designation will help in affiliating the development and accelerated review of CLR as a potential therapy for the treatment of LPL/WM. With the designation, Cellectar will now have regular meetings with the agency’s review team during the development period of the drug. This will include meetings to deliberate over study design and required data for approval.