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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 11 minutes ago
- 2 min read
04/12/2025
BMS' Breyanzi received FDA approval for R/R MZL (Ref)
The US FDA granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (Breyanzi; CD19-directed CAR-T cell therapy) for the treatment of adult patients with R/R marginal zone lymphoma who have received at least two prior lines of systemic therapy.
The approval is based on results from the MZL cohort of the TRANSCEND FL trial
Lynelle B. Hoch, President, Cell Therapy Organization, BMS: “The FDA approval of Breyanzi for relapsed or refractory marginal zone lymphoma further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients.
Breyanzi is the first and only CAR T cell therapy approved for this patient population, demonstrating Bristol Myers Squibb’s deep commitment to expanding access and reaching as many patients as possible with this innovative, practice-changing treatment.”
J & D Pharmaceuticals' investigational therapy received the FDA orphan drug designation for HCC (Ref)
The US FDA granted the orphan drug designation to J & D Pharmaceuticals' investigational therapy for the treatment of Hepatocellular Carcinoma.
Lenard Lichtenberger, PhD, Chief Scientific Officer: "Receiving Orphan Drug Designation is yet another significant milestone for J & D Pharmaceuticals. This designation adds to the two previous orphan drug designations we received and continues to underscore the urgent need for innovative therapies for HCC patients and strengthens our commitment to developing solutions that we expect to transform the lives of those affected by this debilitating condition not just by adding years to their lives but life to those years."
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