The EC conditional marketing authorisation was based on the CARTITUDE-1 study, in which 98% of patients responded to the treatment and 80% of the patients who responded experienced a stringent complete response
Janssen is a pharmaceutical company based in Beerse, Belgium. (Credit: Vysotsky/Wikipedia)
Janssen, the pharmaceutical company Johnson & Johnson (J&J), has received the European Commission (EC) conditional marketing authorisation for Carvykti (ciltacabtagene autoleucel; cilta-cel) to treat a type of relapsed and refractory multiple myeloma (RRMM).
Carvykti is a chimeric antigen receptor T-cell (CAR-T) therapy, jointly developed by Janssen and Legend Biotech, under an exclusive license and collaboration agreement, signed in December 2017.
The drug is designed to identify and destroy the cells that express B-cell maturation antigen (BCMA) and is administered as a single infusion.
The EC indicated Carvykti for RRMM in adults, who received at least three prior therapies, and experienced disease progression with the last therapy.
The prior therapies include an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody.
Earlier this year, the US Food and Drug Administration (FDA) approved Carvykti for the same indication.
Janssen-Cilag EMEA haematology therapeutic area lead Edmond Chan said: “At Janssen, we are building on nearly 20 years of commitment towards changing what a multiple myeloma diagnosis means for patients and are intent on addressing the high unmet needs that still remain.
“With today’s approval of cilta-cel in Europe, we are pleased to be delivering a new approach to the way in which healthcare professionals can tackle, and hopefully one day overcome this complex disease.”
The EC granted CMA for Carvykti based on results from the CARTITUDE-1 study in 179 adult patients who received a median of six prior treatment regimens.
In the study, 98% of RRMM patients responded to the treatment with Carvykti, and 80% of the patients who responded had a stringent complete response (sCR).
The sCR is a measure used when a physician could not observe any signs or symptoms of the disease through imaging or other tests after treatment.
The most common adverse reactions include neutropenia, cytokine release syndrome (CRS), pyrexia, thrombocytopenia, anaemia, leukopenia, lymphopenia, musculoskeletal pain, hypotension, and fatigue, among others.
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 today’s approval possible.”