News

Abecma OK’d in US to take earlier in treatments for multiple myeloma

The U.S. Food and Drug Administration (FDA) has expanded the indication of Abecma (idecabtagene vicleucel) to allow its use earlier in the therapy regimen for adults with difficult-to-treat multiple myeloma. The CAR T-cell therapy, developed by Bristol Myers Squibb (BMS) and 2seventy bio, was already approved in…

Steroid-free Venclexta combo shows promise in myeloma cells

Combining the cancer therapy Venclexta (venetoclax) with a molecule called 5-azacytidine (5-aza) increased the former’s ability to kill lab-grown cancer cells derived from a range of different multiple myeloma patients regardless of their disease stage, a study showed. While Venclexta is known to benefit only myeloma patients with…

CAR T-cell therapy recommended as earlier treatment line for RRMM

An advisory committee of the U.S. Food and Drug Administration (FDA) has unanimously recommended extending the approval of Janssen’s Carvykti (ciltacabtagene autoleucel) as an earlier line of treatment for adults with relapsed or refractory multiple myeloma (RRMM). The 11 -0 vote by the Oncologic Drugs Advisory Committee was…

Approval of a Darzalex Faspro therapy combo is sought in Europe

Johnson & Johnson has applied to the European Medicines Agency (EMA) for approval of its under-the-skin formulation of Darzalex (daratumumab), called Darzalex Faspro (daratumumab and hyaluronidase-fihj), in combination with a standard triple-therapy regimen for treating adults with newly diagnosed multiple myeloma who are eligible for…

Myeloma Action Month to focus on bringing hope through action

Myeloma Action Month (MAM) is observed each March to call attention to multiple myeloma and the people affected by it, and this year’s event will focus on bringing hope to patients and caregivers through action. The international campaign is designed to improve awareness of myeloma among policymakers, researchers,…

FDA OKs less frequent Tecvayli dosing for treatment responders

The U.S. Food and Drug Administration (FDA) has cleared an every-other-week dosing regimen of Tecvayli (teclistamab) for relapsed or refractory (hard-to-treat) multiple myeloma (RRMM) patients who have responded well to the therapy’s standard weekly dosing. Tecvayli was initially approved in 2022 for adults with RRMM who had…

Elrexfio now approved in Canada as recurring myeloma treatment

Health Canada has granted conditional approval to Pfizer’s Elrexfio (elranatamab-bcmm), expanding the list of countries where the medication can be used for adults with multiple myeloma whose cancer has returned and who have not responded to previous treatment. The conditional approval, officially a Notice of Compliance, will require…

Blenrep delays disease progression by nearly 3X versus Darzalex

GlaxoSmithKline (GSK)’s Blenrep (belantamab mafodotin) significantly reduced by more than half the risk of disease progression or death in people with relapsed or refractory multiple myeloma (RRMM) relative to Darzalex (daratumumab). A nearly three times greater delay in disease progression and a 43% lower risk of death was associated…

Regeneron seeking approval of linvoseltamab for RRMM in US, EU

The European Medicines Agency has agreed to review Regeneron Pharmaceuticals’ application seeking approval of its investigational therapy linvoseltamab for adults in Europe with relapsed or refractory multiple myeloma (RRMM), according to a company press release. A similar application was submitted to the U.S. Food and Drug Administration…