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The European Commission has granted conditional approval to CAR-T cell therapy Carvytki (cilta-cel) for the treatment of relapsed and refractory myeloma.

It has been specifically approved for myeloma patients who have received at least three prior treatments, including a proteasome inhibitor (such as bortezomib and carfilzomib), an immunomodulatory agent (such as lenalidomide or pomalidomide) and an anti-CD38 antibody (such as daratumumab or ixatuximab), and have demonstrated disease progression on last treatment. You can find the full press release here.


Carvytki is the second anti-BCMA CAR-T cell therapy to receive approval from the European Commission, following the approval of ide-cel (Abecma). Commission approval means it is safe and effective to be prescribed in European countries.

However, for patients to access it in national healthcare systems there are additional funding and assessment hurdles for it to pass through.


Kate Morgan, Head of Policy and Access at Myeloma Patients Europe, commented:

“Heavily pre-treated myeloma patients need access to safe and effective treatments, which prolong survival and improve quality of life. Conditional approval of Carvytki is therefore good news for patients. However, in Europe, we know this is only the first hurdle to pass before patients can access it – particularly given the complex manufacturing process associated with CAR-T. We will be working hard with our members, industry partners and other stakeholders to seek availability of CAR-T for myeloma patients across Europe.”


The European Commission usually approves new medicines using data from large Phase III clinical trials, which assess and compare a treatment in many patients. However, conditional marketing authorisation (CMA) means the EMA has approved the treatment using less extensive data than normal. This is because the EMA considers there to be an unmet need for the treatment and that the benefits of approving Carvytki outweigh the risks.


Carvykti has been approved on the basis of an early phase clinical trial, known as CARTITUDE-1, which showed deep and long-lasting responses in patients who were heavily pre-treated. 98% of patients responded to therapy, with 80% of these patients experiencing a stringent complete response (sCR), a very deep response to treatment. It has also been supported from safety data from the CARTITUDE-2 clinical trial.


Following CMA, the EMA and manufacturers will continue to monitor the safety, efficacy and approval of Carvykti as more data becomes available from ongoing clinical trials.


What is CAR-T? Where can I find further information?

CAR-T cell treatment genetically programmes, through a complex manufacturing process, immune cells (known as T cells) to find a specific protein (such as BCMA) on myeloma cells. When reintroduced into patients’ bodies, CAR-T boosts the ability of the T-cells to find and destroy myeloma cells.

MPE has followed the development of CAR-T in recent years, see the materials below to find out more:

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