Janssen Receives Positive CHMP Opinion for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma
February 23, 2024 – Clinical Trials – CAR T-cell, CHMP, EMA, Janssen, Johnson & Johnson, RRMM
- Results from the phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment
- Most patients with multiple myeloma relapse after current standard treatments and remain in need of additional therapeutic options at earlier stages of the disease.
23 February 2024 — Beerse, Belgium — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a type II variation for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM). The recommended indication for cilta-cel is for the treatment of adult patients with RRMM, who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have demonstrated disease progression on the last therapy and are refractory to lenalidomide. Cilta-cel is the first chimeric antigen receptor (CAR) T-cell therapy to receive a positive CHMP opinion for the treatment of this patient population, as early as after first relapse. Cilta-cel is an innovative CAR T-cell therapy directed against B-cell maturation antigen (BCMA), a protein that is highly expressed on myeloma cells.
“Early resistance to standard treatments is becoming more common in patients with lenalidomide-refractory multiple myeloma, highlighting a need for new options earlier in the course of treatment,” said Edmond Chan MBChB MD (Res), senior director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited, a Johnson & Johnson Company. “Today’s recommendation from the CHMP recognises the potential of cilta-cel to significantly improve outcomes for eligible patients with relapsed and refractory multiple myeloma, as early as after first relapse.”
The CHMP recommendation for cilta-cel is supported by data from the CARTITUDE-4 study (NCT04181827), the first randomised phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.
“We are committed to the advancement of cilta-cel and other immunotherapies, as we aim to improve outcomes for patients and redefine the multiple myeloma treatment paradigm,” said Sen Zhuang MD PhD, vice president, Clinical Research and Development, Johnson & Johnson Innovative Medicine. “Today’s milestone represents an important step forward in the treatment of this complex disease and in our ultimate goal of one day delivering a cure.”
Cilta-cel is currently approved under conditional marketing authorisation (CMA) for the treatment of adults with RRMM, after three prior lines of therapy. In further positive news, the CHMP have now recommended converting the CMA to a standard marketing authorisation, as the obligations of the conditional approval have now been met.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. Learn more at www.janssen.com/emea.
