Author Archives: Joana Carvalho

EMA Plans Speedy Review of Cilta-cel, CAR T-cell Therapy for Advanced Myeloma

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…

Jakafi Plus Steroid Continuing to Treat Multiple Myeloma in Phase 1 Trial

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…

Oncopeptides Will Seek Conditional Approval of Melflufen in Europe

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…

FDA Office Favors Antibody-drug Conjugate for Advanced Multiple Myeloma

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…