The CMA is supported by the open-label, multi-centre Phase Ib/II CARTITUDE-1 clinical trial of cilta-cel to treat RRMM.
The European Commission (EC) has granted Conditional Marketing Authorization (CMA) for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel; cilta-cel) to treat relapsed and refractory multiple myeloma (RRMM) in adult patients.
The treatment is intended for RRMM patients who have previously received a minimum of three therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and should have had progression of disease following the last therapy.
A chimeric antigen receptor T-cell (CAR-T) therapy, cilta-cel features two B-cell maturation antigen (BCMA)-acting single domain antibodies and is given as a single infusion.
Janssen Biotech had signed an exclusive global licence and partnership agreement with Legend Biotech in December 2017 for developing and marketing cilta-cel.
The CMA from the regulatory agency is supported by the open-label, multi-centre Phase Ib/II CARTITUDE-1 clinical trial of cilta-cel to treat RRMM.
According to the trial findings, a single infusion of cilta-cel offered ‘deep and durable’ responses, with 98% of trial subjects responding to therapy at a median follow-up time of 18 months.
Furthermore, 80% of the subjects attained a stringent complete response (sCR), which is defined by a physician being unable to detect any disease signs or symptoms through imaging or other tests following treatment.
Cilta-cel’s safety was analysed in 179 adults in two open-label trials. Neutropenia, cytokine release syndrome (CRS), pyrexia and thrombocytopenia among others were found to be the most common adverse reactions.
The CARTITUDE-1 trial is underway to analyse the longer-term safety and efficacy profile of cilta-cel.
An incurable blood cancer, multiple myeloma impacts a kind of white blood cell called plasma cells, which are seen in the bone marrow.
Janssen Research & Development Oncology Clinical Research vice-president Sen Zhuang said: “The approval of Janssen’s first cell therapy is testament to our ongoing commitment to advance science and transform outcomes for those living with multiple myeloma.
“We are deeply thankful to the patients, their families, the nurses, and the teams of researchers and study centres who have participated in the clinical study of cilta-cel and made the approval possible.”
The latest development comes after the company discontinued the collaboration and licence agreements with Bavarian Nordic to develop vaccines for hepatitis B and human papillomaviruses (HPV).
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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