Janssen is applying to the European Commission for approval of a new indication for CARVYKTI®

05.06.2023 17:57

The application to the European Medicines Agency is based on data from the phase III CARTITUDE-4 study, which is evaluating the safety profile and efficacy of cilta-cel in the treatment of patients who have received up to three prior lines of therapy became. [1] CARTITUDE-4 is the first randomized phase III study to examine the effectiveness of cell therapy after the first relapse in multiple myeloma. [1,2]

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on June 2 the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma.

“The European Commission's previous approval confirmed the potential for cilta-cel to positively impact outcomes for people with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB MD (Res), Senior Director, EMEA Therapeutic Area Lead Hematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step to enable patients to benefit from this CAR-T therapy at an earlier stage of their treatment. If approved, this will be the first and only CAR-T therapy available for the second-line treatment of patients with relapsed and refractory multiple myeloma.”

The application is supported by data from the CARTITUDE-4 trial (NCT04181827), the first phase III randomized trial to evaluate the efficacy and safety profile of cilta-cel compared to pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. [1]

Results from the CARTITUDE-4 trial were presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, on Monday, June 5, 2023; presented at 4:45 p.m. CEST.

“This submission is a testament to our tireless commitment to advancing science, improving outcomes, challenging what the diagnosis of multiple myeloma means to patients, and ultimately working toward our goal of one day curing this complex disease,” said Sen Zhuang, MD, Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “We look forward to working with the EMA to develop this potential new indication for cilta-cel for the treatment of multiple myeloma as soon as possible.”

credentials

[1] ClinicalTrials.gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). Available under: https://clinicaltrials.gov/ct2/show/NCT04181827?term=JNJ-68284528&phase=2&draw=2&rank=1. Last accessed: May 2023.
[2] ClinicalTrials.gov. Search results for “CAR-T”, “Multiple Myeloma”, “Phase 3 studies”. Available under: https://clinicaltrials.gov/ct2/results?term=CAR-T&cond=Multiple+Myeloma&age_v=&gndr=&type=&rslt=&phase=2&Search=Apply. Last accessed: May 2023.