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EMA recommends a new indication for daratumumab in adult patients with newly diagnosed myeloma who are eligible for autologous stem cell transplant

On 19 September the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for daratumumab (Darzalex®, commercialised by Janssen). The new indication is a combination of daratumumab, bortezomib, lenalidomide and dexamethasone and it brings a significant benefit with respect to progression-free survival compared to…

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The National Institute for Health and Care Excellence (NICE) approves the use of elranatamab as a fourth-line treatment for myeloma in England and Wales

  On the 21st of June NICE, the United Kingdom’s public body for medicine appraisals, approved the use of the UK’s first bispecific drug for myeloma, elranatamab. Evidence from an ongoing clinical trial showed that the drug can increase the length of time people are in remission. Based on this evidence, elranatamab, commercially known as…

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MPE comments on the second implementing act of the EU health technology assessment (HTA) regulation (EU HTAR)

The EU Health Technology Assessment (HTA) Regulation (EU HTAR) entered into force in January 2022 and will be applied starting in January 2025. It aims to improve the availability of medicines and certain medical devices by establishing EU level joint clinical assessments and joint scientific consultations. It also sets rules for the involvement of patients, clinical experts…

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European Commission approves CAR T-cell therapy ciltacabtagene autoleucel in earlier lines of therapy for relapsed and refractory myeloma

The European Commission has approved marketing authorisation extension for the CAR-T treatment ciltacabtagene autoleucel (Carvytki®), also known as cilta-cel, for use in patients who have received at least one prior therapy, including an immunomodulatory agent (IMiD – such as lenalidomide and pomalidomide) and a proteasome inhibitor (PI – such as bortezomib or carfilzomib), have demonstrated disease progression…

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