The U.S. Food and Drug Administration has granted accelerated approval to Regeneron Pharmaceuticals’ (NASDAQ:REGN) Lynozyfic (linvoseltamab-gcpt) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, the company announced Wednesday.
Sanofi has taken a small step towards potentially overturning a recent rejection by NICE for NHS use of Sarclisa as a treatment for relapsed and refractory multiple myeloma (RRMM).
Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted approval by the European Commission (EC) for use in certain patients with relapsed or refractory multiple myeloma (RRMM).
Johnson & Johnson has become the first drugmaker to get FDA approval for a drug targeting GPRC5D, getting the nod for its bispecific antibody Talvey for a group of patients with relapsed or refractory multiple myeloma.
The US Food and Drug Administration (FDA) has placed a clinical hold on Arcellx’s IMMagine-1 Phase II study of CART-ddBCMA, a BCMA-specific CAR-modified T-Cell therapy, for the treatment of relapsed or refractory multiple myeloma (RRMM).
ALX Oncology has reached a clinical trial partnership and supply agreement with Sanofi to assess evorpacept in combination with SARCLISA (isatuximab-irfc) and dexamethasone to treat patients with relapsed or refractory multiple myeloma (RRMM).
The BCMA- and CD3-directed bispecific antibody REGN5459 led to fast onset, deep, and dose-dependent responses sustained over time, with a high frequency of manageable low-grade cytokine release syndrome (CRS) in patients with relapsed/refractory multiple myeloma, according to findings from a first-in-human phase 1/2 trial (NCT04083534) that were presented at the 2023 AACR Annual Meeting.1,2
Oncopeptides released positive data Wednesday from the Phase III LIGHTHOUSE trial of Pepaxto (melflufen) in relapsed refractory multiple myeloma (RRMM) patients.
This comes one month after the FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting in late September that resulted in a 14-2 vote against Pepaxto.
The Janssen Pharmaceutical Companies of Johnson & Johnson has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for talquetamab to treat relapsed or refractory multiple myeloma in adult patients.