Japan has granted manufacturing and marketing approval for the supplemental new drug application (sBLA) of Bristol-Myers Squibb (BMS) for Abecma (idecabtagene vicleucel) to treat relapsed or refractory multiple myeloma (RRMM).
Under the expanded indication, RRMM patients who previously received a minimum of two treatments, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, are eligible to receive Abecma.
Abecma is a chimeric antigen receptor (CAR) T-cell immunotherapy directed at the B-cell maturation antigen (BCMA).
Japan granted approval based on interim data from the randomised, open-label, controlled, international Phase III KarMMa-3 clinical trial of Abecma in RRMM patients.
The study evaluated Abecma’s safety and efficacy versus standard treatments, with median progression-free survival (mPFS) as its primary endpoint.
Findings showed that Abecma offered an mPFS of 13.3 months compared to 4.4 months in subjects who received a standard treatment.
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This indicates a statistically significant and clinically meaningful rise in mPFS following Abecma treatment with 51% reduced disease progression or mortality risk compared to the standard regimen.
On the key secondary endpoint of overall response rate (ORR), Abecma treatment resulted in a 71.3% ORR versus 41.7% in the standard treatment arm.
No new safety concerns were observed in the trial subjects.
Bristol Myers Squibb Japan research and development head Makoto Sugita stated: “Treatment options for patients with RRMM are limited, and we are pleased that Abecma is the first CAR T cell therapy to be approved for earlier use as a treatment option to address the unmet needs of these patients.
“We remain committed to researching and developing innovative therapies to transform patient lives with serious diseases through science.”
BMS has also expanded a strategic partnership with IMIDomics to expedite research and development in immune-mediated inflammatory diseases.
The companies will collaborate to obtain clinical and epidemiological data from people with Sjögren’s disease and atopic dermatitis to generate biomolecular data.
The US Food and Drug Administration granted priority review for BMS’s sBLA of Opdivo (nivolumab) plus cisplatin-based chemotherapy as a first-line therapy in adults with unresectable or metastatic urothelial carcinoma.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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