Is Nyla Still in Clinical Trials?
No, Nyla (linvoseltamab) is no longer solely in clinical trials. The bispecific T-cell engager from Regeneron received FDA accelerated approval on February 12, 2024, as Nylaq for relapsed/refractory multiple myeloma after at least three prior therapies.[1] Approval relied on the phase 1/2 LINKER-MM1 trial, where it showed 71% overall response rate and 46% complete response rate at the 200 mg dose.[2]
What Trial Data Led to Approval?
LINKER-MM1 enrolled 117 patients at the recommended dose. Median progression-free survival reached 12.4 months, with 60% of responders maintaining response at one year. Cytokine release syndrome occurred in 58% (mostly grade 1/2), and infections in 55%.[2] Full approval requires confirmatory phase 3 data from LINKER-MM3 versus standard therapies.
Are There Ongoing Nyla Trials?
Yes, multiple trials continue. Phase 3 LINKER-MM3 (NCT04973137) tests Nylaq against pomalidomide plus dexamethasone in similar patients, with recruitment ongoing.[3] Earlier trials like phase 1/2 LINKER-MM2 explore combinations with other agents. No phase 4 post-marketing studies appear listed yet.[3]
When Can Patients Access Nylaq?
Nylaq launched commercially in the US in March 2024 at $15,080 per infusion (200 mg), or about $265,000 annually for continuous dosing.[4] It's available through Regeneron's distribution; eligibility requires prior exposure to a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.
How Does Nylaq Compare to Other Bispecifics?
| Drug | Approval Date | ORR in RRMM | Key Trial |
|------|---------------|-------------|-----------|
| Nylaq (linvoseltamab) | Feb 2024 | 71% | LINKER-MM1[2] |
| Elrexfio (elranatamab) | Aug 2023 | 61% | MagnetisMM-3[5] |
| Talvey (talquetamab) | Aug 2023 | 73% | MonumenTAL-1[5] |
Nylaq targets BCMA, like Elrexfio, but subcutaneous dosing every 1-4 weeks suits outpatient use. Talvey targets GPRC5D, with higher neurotoxicity risk.
What Patent and Exclusivity Details Apply?
Nylaq has orphan drug exclusivity until 2027 and potential pediatric exclusivity extension. Key US patents cover the antibody construct (expires ~2038) and manufacturing; Regeneron lists no imminent expirations on DrugPatentWatch.[6] No Paragraph IV challenges filed yet.
[1]: FDA.gov - Nylaq Approval (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-nylaq-relapsed-or-refractory-multiple-myeloma)
[2]: NEJM - Linvoseltamab in RRMM (https://www.nejm.org/doi/full/10.1056/NEJMoa2312054)
[3]: ClinicalTrials.gov - Nyla Searches (https://clinicaltrials.gov/search?term=linvoseltamab)
[4]: Regeneron Press Release (https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-fda-approval-nylaqtm-linvoseltamab-hcqs-relapsed)
[5]: FDA Labels - Elrexfio/Talvey
[6]: DrugPatentWatch.com - Linvoseltamab (https://www.drugpatentwatch.com/p/tradename/NYLAQ)