Linvoseltamab (Lynozyfic) is anti CD38 mab, which used for relapsed or refractory multiple myeloma. learn about its uses, dose, side effects.

Phase 2 safety and efficacy data showed fixed-duration linvoseltamab prevented disease progression and produced deep responses in pts w/ high-risk smoldering multiple myeloma.

The CHMP has issued a positive opinion for linvoseltamab in relapsed/refractory multiple myeloma.

Hans Lee, MD, and Nisha Joseph, MD, discuss the FDA approval of linvoseltamab for the treatment of patients with relapsed/refractory multiple myeloma.

On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to linvoseltamab-gcpt for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received...

Linvoseltamab earned EC approval for relapsed/refractory multiple myeloma after at least 3 prior lines of therapy.

70% of heavily pretreated patients responded to linvoseltamab (Lynozyfic)

Für intensiv vorbehandelte Myelompatienten ist mit Linvoseltamab ein neuer bispezifischer Antikörper verfügbar. Er richtet sich gegen das B-...

Regeneron Pharmaceuticals (NASDAQ: REGN) has received FDA accelerated approval for Lynozyfic™ (linvoseltamab-gcpt), the first BCMAxCD3 bispecific antibody for treating relapsed or refractory multiple myeloma in adults who have received at least four prior therapies.The approval is based on the LINKER-MM1 trial results, where patients (n=80) achieved a 70% objective response rate, with 45% reaching complete response or better. The median duration of response was not reached, with an estimated 89% duration of response at 9 months.Lynozyfic features a unique dosing schedule, allowing administration every two weeks starting at week 14, and potentially every four weeks with good response. The treatment includes mandatory hospitalization during initial dosing for safety monitoring.

Linvoseltamab monotherapy produced responses and was safe in newly diagnosed multiple myeloma.

TARRYTOWN, N.Y. , July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for...

Linvoseltamab demonstrated strong early activity and a more favorable safety profile in patients with high-risk smoldering multiple myeloma (HR-SMM) compared with relapsed or refractory MM, according ...

(MedPage Today) -- TORONTO -- Linvoseltamab (Lynozyfic) appeared effective in patients with high-risk smoldering multiple myeloma (HR-SMM), according to preliminary phase II trial data. With a median follow-up of 3.9 months among 19 evaluable... Source link

Mezigdomide plus elranatamab yielded a 100% ORR in MELT-MM, as other IMS 2026 abstracts covered cevostamab, anito-cel vs cilta-cel, and linvoseltamab in HR-SMM.

Regeneron's linvoseltamab earns CHMP backing for relapsed/refractory multiple myeloma patients who've failed three prior therapies, with FDA decision expected July 2025.

FDA reviews Regeneron's linvoseltamab for resistant multiple myeloma treatment. Manufacturing issues resolved, targeting patients with 3-4 prior therapies.

Bispecific antibody yields 100% overall response rate in early data from phase II trial

FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

Regeneron Pharmaceuticals’ multiple myeloma drug linvoseltamab has clinical trial results showing complete responses in 90% of patients who have light chain amyloidosis, a rare blood disease. The preliminary data were presented during the annual meeting of the American Society of Clinical Oncology.