CHMP recommends approval of Janssen’s first CAR-T therapy
pharmafile | March 29, 2022 | News story | Manufacturing and Production |
Johnson & Johnson have announced the CHMP recommendation of marketing authorisation of ciltacabtagene autoleucel (cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma, who have received at least three prior therapies.
The recommendation is for patients who have received an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and 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.
“Although significant advances have been made in the treatment of multiple myeloma, it remains a heterogenous disease that is challenging to treat,” said Edmond Chan MBChB MD (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Therapeutic innovations with novel mechanisms of action are urgently needed. Our focus is on bringing transformative treatments to the medical community, like cilta-cel, for patients with multiple myeloma in need of new options.”
CAR-T therapy is a highly personalised technology where a patient’s own T-cells are re-programmed to target and kill cancer cells. It is administered as a single infusion.
“At Janssen, we are resolute in our commitment to advance science and improve outcomes for patients diagnosed with multiple myeloma,” said Sen Zhuang, MD, PhD, Vice President, Oncology Clinical Research, Janssen Research & Development, LLC. “Today’s CHMP positive opinion marks important progress in the ongoing clinical development and registration of cilta-cel, globally.”
Multiple myeloma is an incurable blood cancer, with around 50% of newly diagnosed patients not reaching five-year survival. Despite the development of additional treatment options in recent years, most people living with multiple myeloma face poor prognoses after being exposed to all three major drug classes to treat the cancer. The recommendation of cilta-el presents a significant new hope for these patients.
Ana Ovey
