FDA Grants Fast Track Designation for CLR 131 in Multiple Myeloma
Posted: Tuesday, May 21, 2019
The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation for CLR 131 for the fourth-line or later treatment of relapsed or refractory multiple myeloma. CLR 131 is a small-molecule radiotherapeutic phospholipid drug-conjugate designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. It is currently being evaluated in the ongoing phase II CLOVER-1 clinical trial (ClinicalTrials.gov identifier NCT02952508) in patients with relapsed or refractory multiple myeloma and other select B-cell lymphomas.
CLOVER-1 is being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers under study include multiple myeloma, chronic lymphocytic leukemia/small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, mantle cell lymphoma, and diffuse large B-cell lymphoma. The study’s primary endpoint is clinical benefit response, with additional endpoints of overall response rate, progression-free survival, median overall survival, and other markers of efficacy following a fractionated dose of 15.625 mCi/m2 dose of CLR 131 administered on days 1 and 8, with the option for a second dose cycle approximately 75 to 180 days later.
In addition to receiving the 2 fractionated doses of CLR 131, patients with multiple myeloma will receive 40 mg of oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma Working Group criteria. Efficacy for all patients with lymphoma will be determined according to Lugano criteria.
