The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended Johnson & Johnson’s 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.
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The FDA previously approved Carvykti in February 2022 for treating adults with R/R MM following four or more lines of therapy.
Johnson & Johnson innovative medicine multiple myeloma disease area leader, vice-president Jordan Schecter stated: “We are pleased with the advisory committee’s support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data.
“As 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.”
The latest development comes after the company filed an sBLA with the FDA for Tremfya (guselkumab) to treat ulcerative colitis.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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