The therapy is designed 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).
In addition, they must have demonstrated disease progression on the last therapy and are refractory to lenalidomide.
RRMM is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.
In RRMM, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.
Cilta-cel is an ‘innovative’ CAR-T therapy directed against B-cell maturation antigen (BCMA), a protein that is highly expressed on myeloma cells.
It is the first CAR-T therapy to receive a positive CHMP opinion for the treatment of this patient population, administered after first relapse.
“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, senior director, EMEA, lead haematology at Janssen.
“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.”
While some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.
“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, vice president, clinical research and development at 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 now approved under conditional marketing authorisation (CMA) for the treatment of adults with RRMM, after three prior lines of therapy.
As a result of the most recent study, the CHMP have now recommended converting the CMA to a standard marketing authorisation, as the obligations of the conditional approval have now been met.
