News

A unanimous vote by a committee of the U.S. Food and Drug Administration (FDA) could lead to an early outcome measure — one known as minimal residual disease, or MRD negativity — being used for accelerated approval of treatments in clinical trials of…

The U.S. Food and Drug Administration (FDA) has approved the CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) as a second line of treatment for adults with relapsed or refractory multiple myeloma (RRMM). The therapy was first approved by the FDA in 2022 for adults who received four or…

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…

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…

The European Commission has approved Bristol Myers Squibb (BMS)’s request to expand the use of the CAR T-cell therapy Abecma (idecabtagene vicleucel) as an earlier line of therapy for adults with multiple myeloma that’s difficult to treat. The therapy was already approved in the European Union (EU) for…

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…

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 (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,…

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…

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…