Negative
25Serious
Neutral
Optimistic
Positive
- Total News Sources
- 3
- Left
- 1
- Center
- 0
- Right
- 0
- Unrated
- 2
- Last Updated
- 1 day ago
- Bias Distribution
- 100% Left
FDA Grants Accelerated Approval to Regeneron Lynozyfic for Relapsed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Regeneron's Lynozyfic (linvoseltamab-gcpt), a BCMAxCD3 bispecific antibody, for adults with relapsed or refractory multiple myeloma (R/R MM) who have undergone at least four prior lines of therapy. This approval is based on data from the Phase I/II LINKER-MM1 trial, which showed a 70% overall response rate and a 45% complete response rate, with durable responses and a median time to first response of less than one month. Updated results from the LINKER-MM2 trial demonstrated that combining linvoseltamab with carfilzomib significantly improved outcomes, achieving a 90% overall response rate and 76% complete response rate, compared to linvoseltamab monotherapy. The FDA label includes warnings about risks such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), but the safety profile was consistent with expectations. Regeneron is further investigating Lynozyfic in earlier treatment settings and other plasma cell disorders, positioning it as a potential new standard of care for multiple myeloma. These developments represent significant progress in addressing unmet needs in heavily pretreated multiple myeloma patients.

- Total News Sources
- 3
- Left
- 1
- Center
- 0
- Right
- 0
- Unrated
- 2
- Last Updated
- 1 day ago
- Bias Distribution
- 100% Left
Negative
25Serious
Neutral
Optimistic
Positive
Related Topics
Stay in the know
Get the latest news, exclusive insights, and curated content delivered straight to your inbox.

Gift Subscriptions
The perfect gift for understanding
news from all angles.