LOUISVILLE, Ky., Aug. 04, 2025 (GLOBE NEWSWIRE) — Onco360(R), the nation's leading independent Specialty Pharmacy, has been selected as a national pharmacy partner by Regeneron Pharmaceuticals for Lynozyfic(TM) (linvoseltamab-gcpt), which has been has granted accelerated approval by the Food and Drug Administration to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.1 Lynozyfic was granted accelerated approval based on response rate and durability of response in the LINKER-MM1 trial.2 “Onco360 is grateful for the opportunity to partner with the Regeneron team and become a specialty pharmacy provider for Lynozyfic,” said Benito Fernandez, Chief Commercial Officer. “We are proud to add this targeted therapy to our portfolio to treat patients with relapsed/refractory multiple myeloma.” Linvoseltamab is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.1 Linvoseltamab is the first FDA-approved BCMAxCD3 bispecific antibody that can be dosed every two weeks starting at week 14, and every four weeks if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy. Lynozyfic is available only through the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS) due to the risk of cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). The FDA accelerated approval for Lynozyfic based on the results of 80 patients with relapsed or refractory multiple myeloma (MM) who were treated with at least 4 lines of therapy in the LINKER-MM1 trial.2 The trial showed that the objective response rate (ORR), the primary endpoint, was 70%, with 45% achieving a complete response (CR) or better as determined by an independent review committee. The median time to first response was 0.95 months and the median duration of response (mDOR) was not reached (95% CI: 12, NE). The estimated DOR was 89% at 9 months (95% CI: 77-95 months) and 72% at 12 months (95% CI: 54-84 months) at median follow-up of 13 months.1 The most frequent adverse reactions greater-than or equal to 20% were musculoskeletal pain, CRS, neutropenia, cough, dyspnea, diarrhea, anemia, fatigue, pneumonia, headache, nausea, and upper respiratory tract infection. CRS was reported in 46% of patients with 35% Grade 1 (35%), 10% Grade 2 (10%), and one case of Grade 3 CRS (0.9%) and no cases of Grades 4 or 5 CRS. The median time to first CRS onset was 11 hours (range: -1.1 to 184 hours), with the median time to resolution of 15 hours (range: 1-76 hours).1 The prescribing information for Lynozyfic has a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome (ICANS) – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity. Due to the risks of cytokine release syndrome and neurologic toxicity, including ICANS, Lynozyfic is available only through a restricted program called the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS). Please read the full prescribing information for Lynozyfic. About Onco360 Oncology Pharmacy Media Contact: Benito Fernandez, Chief Commercial Officer References: 1Lynozyfic (linvoseltamab) [Package Insert]. Tarrytown, NY. Regeneron Pharmaceuticals. 2025. 2Bumma N, Richter J, Jagannath S, et al. Linvoseltamab for treatment of relapsed/refractory multiple myeloma. J Clin Oncol. 2024;42(22):2702-2712. doi:10.1200/JCO.24.01008
Onco360 is the nation's largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
Benito.fernandez@onco360.com
516-640-1332
