The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended Johnson & Johnson鈥檚 Carvykti (ciltacabtagene autoleucel, cilta-cel) to treat relapsed or refractory multiple myeloma (r/r MM).
A B-cell maturation antigen-targeting, genetically modified autologous T-cell immunotherapy, Carvykti is intended for adult r/r MM patients who have previously undergone a minimum of one line of treatment including a proteasome inhibitor and an immunomodulatory agent.
The recommendation follows a review of data from the Phase III CARTITUDE-4 study, which demonstrated the efficacy and safety of the therapy compared to alternative treatments.
The committee voted unanimously in favour of Carvykti as its risk-benefit profile for the proposed indication was favourable.
The randomised trial assessed the immunotherapy against pomalidomide, a bortezomib and dexamethasone combination and a daratumumab, pomalidomide and dexamethasone combination.
Based on the trial, a supplemental biologics licence application (sBLA) is currently under FDA review, with a decision under the Prescription Drug User Fee Act expected by 5 April 2024.
The FDA previously approved Carvykti in February 2022 for treating adults with R/R MM following four or more lines of therapy.
Johnson & Johnson听innovative medicine multiple myeloma disease area leader, vice-president Jordan Schecter stated: 鈥淲e are pleased with the advisory committee鈥檚 support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data.
鈥淎s a physician and researcher committed to advancing patient care, the potential of Carvykti in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma.鈥�
The latest development comes after the company filed an sBLA with the FDA for Tremfya (guselkumab) to treat ulcerative colitis.
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