Carvykti (ciltacabtagene autoleucel) had support through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs.
EMA’s human medicines committee (CHMP) recommended authorization for ciltacabtagene autoleucel (cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and who have demonstrated disease progression on the last therapy.
Cilta-cel is a chimeric antigen receptor T-cell (CAR-T) therapy featuring two B-cell maturation antigen (BCMA)-targeting single domain antibodies.
In December 2017, Janssen entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA Inc to develop and commercialize cilta-cel.
The positive CHMP opinion was supported by data from the CARTITUDE-1 study; results from that trial were presented at the American Society of Hematology (ASH) 2021 annual meeting.
Sen Zhuang, VP, oncology clinical research, Janssen R&D, said the opinion marks important progress in the ongoing clinical development and registration of cilta-cel, globally.
The US Food and Drug Administration (FDA) approved the Janssen therapy in February this year.
Additional indication recommended for Novartis drug
EMA’s committee also recommended several other drugs for approval at its March 2022 meeting.
Novartis received a positive CHMP opinion for Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe - the positive opinion paves way for a third indication in Europe for the therapy.
The CHMP opinion is based on the Phase II global ELARA trial, which was said to show high response rates in heavily pretreated patient: 69% experienced a complete response, with an 86% overall response rate and a robust safety profile.
And the committee gave backing for other extensions of indication for medicines that are already authorized in the EU: Cabometyx, Jakavi, Keytruda, for which there were two extensions, and Polivy.
The CHMP also advised the granting of a marketing authorization for two medicines, submitted in hybrid applications, meaning they relied in part on the results of pre-clinical tests and clinical trials of an already authorized reference product, and in part on new data: Camcevi (leuprorelin) for the treatment of hormone-dependent prostate cancer and Zolsketil pegylated liposomal (doxorubicin) for the treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma.