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CLR 131 receives FDA fast track designation in relapsed/refractory multiple myeloma

May 14, 2019

On 13 May 2019, it was announced that CLR 131 has been granted fast track designation by the U.S. Food & Drug Administrationfor the treatment of relapsed/refractory multiple myeloma (RRMM) as fourth line therapy (or later). 1

What is CLR 131? 2

CLR 131 is a radioiodinated phospholipid ether-drug conjugate that utilizes malignant cells selective uptake and retention of phospholipid ethers. It is being investigated in MM and other B-cell hematologic cancers.

Founding trial: CLOVER-1 2,3

In February 2019, results from the CLOVER-1 trial ( NCT02952508) were announced. The phase II study of CLR 131 in 10 patients with RRMM demonstrated an overall response rate of 30%, with one very good partial response and two partial responses. The MM Hub coverage of the phase II results can be found here.

What is fast track designation? 4

The FDA fast track designation aims to speed up the development and review process of drugs that meet an unmet medical need, bringing drugs to patients in a more time-efficient manner. A therapy or drug may be considered for fast track designation if it fills an unmet medical need for which there is no current therapy, or if it demonstrates superiority to the existing treatment option in terms of increased efficacy, reduced toxicity, facilitating a faster diagnosis or anticipating a public health requirement.

  1. Cellectar Receives FDA Fast Track Designation For CLR 131 In Relapsed Or Refractory Multiple Myeloma. https://myelomabeacon.org/pr/2019/05/13/clr131-fast-track-designation-us-fda/[accessed 2019 May 13]
  2. Study of CLR 131 in Relapsed or Refractory Select B-Cell Malignancies (CLOVER-1). https://clinicaltrials.gov/ct2/show/NCT02952508[accessed 2019 May 13]
  3. Cellectar Reports Positive Top-line Response Rate of 30% from R/R Multiple Myeloma Cohort in Ongoing Phase 2 Study of CLR 131. https://globenewswire.com/news-release/2019/02/25/1741555/0/en/Cellectar-Reports-Positive-Top-line-Response-Rate-of-30-from-R-R-Multiple-Myeloma-Cohort-in-Ongoing-Phase-2-Study-of-CLR-131.html[accessed 2019 May 13]
  4. Fast Track. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track[accessed 2019 May 13]