Johnson & Johnson’s combination therapy Tec-Dara received its third approval under the Food and Drug Administration’s Commissioner’s National Priority Voucher program last week, continuing recent advances in the multiple myeloma field, according to a March 9 statement. This development follows GlaxoSmithKline’s Blenrep returning to the market after being withdrawn in November 2022; it secured new FDA approval as a combination regimen for third-line treatment of multiple myeloma last October.
The continued approvals highlight ongoing efforts to improve outcomes for patients with multiple myeloma, a cancer that remains difficult to cure. Saad Usmani, scientific advisory board member at the International Myeloma Foundation, said in an email to BioSpace that while treatments have advanced, “multiple myeloma remains a disease that is treated and managed, not cured.” Usmani added there is growing interest in defining how long patients should be treated and expressed optimism about future prospects: “I am very confident that we will be able to provide 20–25+ year disease control and potentially cure a significant number of patients in the next decade.”
Recent guidance from the FDA aims to accelerate access to novel drugs showing early efficacy signals. Among emerging therapies is Regeneron’s bispecific antibody Lynozyfic, which targets BCMA and CD3 proteins. After initial regulatory setbacks due to manufacturing issues, Lynozyfic achieved accelerated approval for fifth-line treatment based on data showing a 70% objective response rate and a 45% complete response rate or better. Rajesh Kumar of DelveInsight said Regeneron refined dosing and safety by allowing some patients monthly dosing instead of biweekly schedules.
AbbVie and Ichnos Glenmark Innovation are developing ABBV-2001, a trispecific antibody targeting BCMA, CD38 on myeloma cells, and CD3 on T cells. Aparna Thakur of DelveInsight described this approach as potentially first-in-class with early trial data indicating a 74% overall response rate among heavily pretreated patients.
Caribou Biosciences is advancing CB-011, an allogeneic CAR T therapy designed for off-the-shelf use. CEO Rachel Haurwitz said current autologous CAR T therapies face access challenges because they require patient-derived cells and lengthy manufacturing times. Phase 1 results showed CB-011 produced a 92% overall response rate with manageable safety concerns.
Other developments include C4 Therapeutics’ cemsidomide—an oral small-molecule degrader targeting transcription factors IKZF1/3—and Exicure’s burixafor, which helps mobilize stem cells for transplantation procedures common in multiple myeloma care.
As new therapies emerge and established drugs return or expand their indications, experts anticipate further improvements in patient outcomes over the coming years.
