Regeneron gets long-awaited FDA okay for myeloma drug
Regeneron's bid to join the US market for BCMA-targeted bispecific antibodies for multiple myeloma has finally been realised after the FDA approved its Lynozyfic drug at a second attempt.
Lynozyfic (linvoseltamab) has been given accelerated approval by the US regulator for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.
The drug is a late entrant into what is starting to become a crowded market for BCMA-directed therapies. It is chasing after rivals including Johnson & Johnson's Tecvayli (teclistamab) and Pfizer's Elrexfio (elranatamab) – both approved for later-line use – as well as GSK's Blenrep (belantamab mafodotin) which recently moved up the treatment ladder into the second-line setting in other markets and is due for an FDA verdict later this month.
Before that, however, Blenrep will have to face an FDA advisory committee that is expected to pay close attention to safety issues, including eye toxicity.
Lynozyfic was originally slated for FDA approval in August 2024, but the agency issued a complete response letter (CRL) that cited compliance issues at a third-party manufacturing partner. In the meantime, Regeneron has won regulatory approval for Lynozyfic in the EU.
All the bispecifics are being positioned as an off-the-shelf alternative to BCMA-directed CAR-T therapies – Bristol-Myers Squibb's Abecma (idecabtagene vicleucel) and J&J/Legend Biotech's Carvykti (ciltacabtagene autoleucel) – which have shown comparable efficacy rates in trials, but are trickier to administer.
Regeneron hopes Lynozyfic will be able to stand out thanks to its "patient-centric response-adapted dosing regimen," which requires infusions every two weeks after an initial induction period, and every four weeks in patients who have a very good partial response (VGPR) after 24 weeks.
In contrast, Tecvayli and Elrexfio and given as subcutaneous injections by healthcare professionals, initially once a week after induction and subsequently every other week if deemed appropriate. Blenrep meanwhile is administered as an IV infusion every three weeks.
"The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community," said Sundar Jagannath of Mount Sinai Hospital in New York City, who was an investigator in the phase 1/2 LINKER-M1 trial that underpins the drug's approval.
In the study, Lynozyfic showed a 70% objective response rate (ORR) with the drug in heavily pre-treated multiple myeloma patients, with 44% achieving a complete response or better, with an estimated duration of response of 72% at 12 months and a median time to first response of just under one month.
"Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials," said Jagannath.
Phase 3 trials of Lynozyfic in earlier lines of therapy and in combination with other multiple myeloma therapies are underway, according to Regeneron.
Check out our web editor Nicole Raleigh's recent interview with Regeneron's therapeutic lead for haemato-oncology, Karen Rodriguez-Loren, on linvoseltamab combination data below:
