Trial Profile
Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma
Status:
Recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 13 May 2025
Price :
$35
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At a glance
- Drugs Linvoseltamab (Primary) ; Linvoseltamab (Primary)
- Indications Multiple myeloma
- Focus Adverse reactions; First in man; Pharmacokinetics; Registrational; Therapeutic Use
- Acronyms LINKER-MM1
- Sponsors Regeneron Pharmaceuticals
Most Recent Events
- 28 Apr 2025 According to a Regeneron Pharmaceuticals media release, based on results from this trial the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM), In the U.S., the FDA accepted for review the Biologics License Application for linvoseltamab in adults with R/R MM with a target action date of July 10, 2025
- 28 Feb 2025 According to a Regeneron Pharmaceuticals media release, company announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory multiple myeloma.The European Commission is expected to announce a final decision in the coming months.
- 11 Feb 2025 According to a Regeneron Pharmaceuticals media release, the U.S. FDA has accepted for review the resubmission of the Biologics License Application for linvoseltamab for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least four prior lines of therapy or those who received three prior lines of therapy and are refractory to the last line of therapy. The target action date for the FDA decision is July 10, 2025.