Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel; ide-cel) have received approval from the US Food and Drug Administration (FDA) to treat adults with relapsed or refractory multiple myeloma (r/r MM).
This chimeric antigen receptor T therapy is now available for patients who have previously received two or more lines of treatment comprising an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
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In November 2023, the regulatory agency delayed the assessment of the supplemental biologics licence application of Abecma for this indication.
The expanded approval now makes the drug available for MM indications in earlier lines for patients who are triple-class exposed.
Approval was granted based on the global, randomised, controlled Phase III KarMMa-3 clinical trial findings.
With a median follow-up of 15.9 months, Abecma demonstrated a more than threefold increase in median progression-free survival (PFS) compared to standard regimens.
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By GlobalDataPatients treated with Abecma experienced a median PFS of 13.3 months versus 4.4 months for those on standard regimens – a 51% reduction in disease progression or mortality risk.
Overall response rates were notably higher with Abecma, with 71% of patients achieving a response and 39% reaching a complete or stringent complete [in which no detectable plasma cells are present in bone marrow] response.
The therapy demonstrated a well-established safety profile with the most adverse effects being low-grade cytokine release syndrome and neurotoxicity.
The global availability of Abecma is expanding, with recent approvals in Japan, Switzerland and the European Union for adult patients.
It is also approved in Great Britain and Israel for patients following three or more previous lines of therapy.
BMS cell therapy commercial head and senior vice-president Bryan Campbell stated: “Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey.
“This approval underpins our commitment to addressing the unmet needs of more patients living with multiple myeloma by improving upon the current treatment paradigm, and we remain steadfast in our pursuit of innovation and advancing cell therapy research to deliver potentially transformative therapies.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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