Author Archives: Joana Carvalho

An accelerated review will be given an application for European Union approval of ciltacabtagene autoleucel (cilta-cel), a potential CAR T-cell therapy for heavily pre-treated multiple myeloma patients, its developer, Janssen, announced. An accelerated assessment, given to medications expected to have a major impact on public health, shortens the regulatory review process…

Combining the corticosteroid methylprednisolone and Jakafi (ruxolitinib), an approved oral therapy for bone marrow disorders, is showing promising effectiveness in heavily pre-treated multiple myeloma patients in an ongoing Phase 1 trial. Findings to date from this open-label study (NCT03110822), which is being sponsored by Onco Therapeutics, showed…

Cevostamab (BFCR4350A), a bispecific antibody developed by Roche, induces durable and deep responses in heavily pre-treated patients with relapsed or refractory multiple myeloma, according to early data from a Phase 1 trial. Preliminary data from the trial, called GO39775 (NCT03275103), also showed cevostamab…

Oncopeptides soon will seek conditional approval of melflufen (melphalan flufenamide) in the EU for the treatment of relapsed or refractory multiple myeloma. The pharmaceutical company now is planning to submit its application — some two years earlier than expected — to the European Medicines Agency (EMA) to request…

NexImmune has dosed the first patient participating in its Phase 1/2 trial of NEXI-002, the company’s investigational T-cell therapy for multiple myeloma. The trial (NCT04505813), which is recruiting participants at several sites across the U.S., aims to enroll 22 to 28 patients with relapsed or…

The National Cancer Institute (NCI) has awarded $1.7 million to support the work of a University of Arkansas for Medical Sciences (UAMS) researcher in developing a therapy that can preserve bone health, and prevent or delay cancer relapse in people with multiple myeloma.

The U.S. Food and Drug Administration (FDA) has granted priority review to Bristol Myers Squibb and Bluebird Bio‘s application requesting the approval of idecabtagene vicleucel (ide-cel) for the treatment of adults with multiple myeloma. The biologics license application (BLA), resubmitted in August, is seeking ide-cel’s approval…

A Phase 1 trial assessing Cellectis’ investigational CAR T-cell therapy, UCARTCS1A, for the treatment of relapsed or refractory multiple myeloma has been placed on hold by the U.S. Food and Drug Administration (FDA), the company announced in a press release. The MELANI-01…

An office of the U.S. Food and Drug Administration (FDA) has recommended that belantamab mafodotin, GlaxoSmithKline’s investigational antibody-drug conjugate, be approved for heavily pretreated relapsed or refractory multiple myeloma patients. The recommendation by the FDA’s  Oncologic Drugs Advisory Committee is for patients who had at least…

When given in combination with Kyprolis (carfilzomib), the investigative therapy Reolysin (pelareorep) elicits a strong inflammatory response — and promising clinical responses — in people with relapsed or refractory multiple myeloma, a Phase 1b trial shows. The study’s findings were presented in a poster, titled…