US EditionWhat's Going On With Bristol-Myers Squibb Stock Friday? - Bristol-Myers Squibb (NYSE:BMY)
Breyanzi shows a 95.5% overall response rate and 62.1% complete response rate in relapsed or refractory marginal zone lymphoma after two prior therapies, based on TRANSCEND FL trial data.
- On Friday, the U.S. Food and Drug Administration approved Breyanzi for adult patients with relapsed or refractory marginal zone lymphoma after at least two prior lines of systemic therapy, based on TRANSCEND FL study results.
- TRANSCEND FL data showed a 95.5% overall response rate and 62.1% complete response rate, with median duration of response not reached and 90.1% responders at 24 months.
- Clinicians should note that CRS typically began and resolved within 5 days, with 76% experiencing any-grade CRS and 32% experiencing neurologic toxicities, including ICANS.
- The approval marks the seventh FDA clearance for Breyanzi across five blood cancer types, with $966 million in sales this year boosting Bristol Myers Squibb's U.S. market position.
- Breyanzi is manufactured from a patient's own autologous T cells and delivered as a one‑time infusion in inpatient and outpatient settings, while Bristol Myers Squibb offers Cell Therapy 360 and coverage assistance.
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13 Articles
What's Going On With Bristol-Myers Squibb Stock Friday? - Bristol-Myers Squibb (NYSE:BMY)
On Thursday, the U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb & Co.’s (NYSE:BMY) Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL). Breyanzi is administered as a one-time infusion. Breyanzi is now the only CAR T cell therapy approved by the FDA for five cancer types, the most of a…
FDA Approves Breyanzi as First CAR T-Cell Therapy for Marginal Zone Lymphoma
The U.S. Food and Drug Administration has granted approval to Breyanzi (Lisocabtagene maraleucel) for use as the first chimeric antigen receptor (CAR) T-cell therapy in adults with marginal zone lymphoma (MZL) who have not responded to or have relapsed after at least two lines of prior therapy. This innovative therapy works by engineering a patient’s own T-cells to better target and destroy cancer cells, and its approval marks a notable step for…
Bristol Myers expands Breyanzi approval to marginal zone lymphoma
Bristol Myers Squibb’s CAR-T therapy Breyanzi has become the first such treatment approved for patients with a rare, slow-growing type of non-Hodgkin lymphoma. The drug was approved Thursday for third-line patients with marginal zone lymphoma ...
First CAR T-Cell Therapy for Marginal Zone Lymphoma Gets FDA Green Light
(MedPage Today) — Patients with advanced marginal zone lymphoma (MZL) now have a CAR T-cell therapy with the FDA approval of lisocabtagene maraleucel (liso-cel, Breyanzi). Approval was supported by findings from the TRANSCEND FL trial and stipulates… Source link : https://www.medpagetoday.com/hematologyoncology/lymphoma/118859 Author : Publish date : 2025-12-05 18:25:00 Copyright for syndicated content belongs to the […] The post First CAR T-Cel…
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