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# FDA Orphan Status for Multiple Myeloma Therapy
- URL: https://www.fdaweb.com/fda-orphan-status-for-multiple-myeloma-therapy/
- Published: 2023-08-23T12:00:00.000Z
- Updated: 2026-09-14T18:52:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155169

FDA has granted Nexcella an orphan drug designation for NXC-201 for treating multiple myeloma. The next-generation BCMA-targeted CAR-T cell therapy is currently being evaluated in the Phase 1b/2a clinical trial called NEXICART-1 (NCT04720313), the company says. To date, over 50 patients have been dosed, and no neurotoxicity has been observed, it adds. Multiple myeloma is an incurable blood cancer, and despite initial remission, most patients are likely to relapse. In the U.S., there are about 35,000 patients diagnosed with the condition annually.