News

Arcellx and Kite Pharma are planning to launch a Phase 3 clinical trial, dubbed iMMagine-3, to test their cell therapy anitocabtagene autoleucel (anito-cel) in people with hard-to-treat multiple myeloma. “We are pleased to start the Phase 3 pivotal trial, iMMagine-3, in the second half of…

NXC-201, an investigational CAR T-cell therapy, has been designated an orphan drug in the European Union (EU) as a potential treatment of multiple myeloma. This status aims to speed the therapy’s clinical development by providing incentives that include reduced regulatory fees. It also gives access to the EU centralized…

At its 15th annual gala, held in New York City this April, the International Myeloma Foundation (IMF) raised more than $675,000 — monies the nonprofit says will be used to advance research into myeloma and to support educational efforts. “The gala was a testament to the strong partnerships,…

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…