Onco360® Selected As Specialty Pharmacy Partner For LYNOZYFIC™ (linvoseltamab-gcpt) To Support Patient Access and Distribution

Onco360®, the nation’s leading independent specialty pharmacy, has been selected as a national pharmacy partner by Regeneron Pharmaceuticals for Lynozyfic™ (linvoseltamab-gcpt), which recently received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (R/R) 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 approval was granted based on the results of the LINKER-MM1 trial, which demonstrated the therapy’s response rate and durability of response.

Linvoseltamab is a bispecific T-cell engaging antibody that binds to the CD3 receptor on T-cells and B-cell maturation antigen (BCMA) on multiple myeloma cells and some healthy B-lineage cells. It is the first FDA-approved BCMAxCD3 bispecific antibody that can be administered every two weeks starting at week 14, and every four weeks if a very good partial response or better is achieved after at least 24 weeks of therapy. Lynozyfic is available only through the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).

Benito Fernandez, Chief Commercial Officer, “Onco360 is grateful for the opportunity to partner with the Regeneron team and become a specialty pharmacy provider for Lynozyfic. We are proud to add this targeted therapy to our portfolio to treat patients with relapsed/refractory multiple myeloma.”

The FDA’s accelerated approval was based on data from 80 patients with R/R multiple myeloma treated with at least four prior lines of therapy in the LINKER-MM1 trial. The trial showed an objective response rate of 70%, with 45% of patients achieving a complete response or better, as assessed by an independent review committee. The median time to first response was 0.95 months, and the median duration of response was not reached, with an estimated 89% of responses ongoing at 9 months and 72% at 12 months, with a median follow-up of 13 months.

The most common adverse reactions reported in 20% or more of patients included musculoskeletal pain, cytokine release syndrome, neutropenia, cough, dyspnea, diarrhea, anemia, fatigue, pneumonia, headache, nausea, and upper respiratory tract infection. CRS occurred in 46% of patients, mostly Grade 1 or 2, with only one Grade 3 case and no Grades 4 or 5 cases. The median time to onset of CRS was 11 hours, with a median resolution time of 15 hours.

Lynozyfic carries a boxed warning for cytokine release syndrome and neurologic toxicity, including ICANS, along with additional warnings for infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity. Due to these risks, Lynozyfic is available only through the restricted Lynozyfic REMS program to ensure safe administration and monitoring.