News

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…

Treating hepatitis may improve patient outcomes in myeloma

A dysregulated immune response against viruses that cause hepatitis may lead to some cases of multiple myeloma (MM) — and in these cases, treating the viral infection may improve the patient’s odds of survival. That’s according to a new study titled “Impact of viral hepatitis therapy…

Obesity, smoking, and poor sleep raise risk of myeloma precursor

Obesity, a history of heavy smoking, and limited sleep are risk factors for developing monoclonal gammopathy of undetermined significance (MGUS), a precursor condition to multiple myeloma, a large U.S. study shows. These findings will help inform future work to identify groups who “may benefit from targeted screening strategies, enhanced…