BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy Approval was supported by MZL cohort data from the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl. follicular lymphoma & MZL In…

ByRidhi Rastogi3 days ago

NEWS

BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has accepted sBLA & granted priority review to Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy (PDUFA: Dec 5, 2025) sBLA is supported by the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl.…

ByRidhi RastogiAugust 5, 2025

VIEWPOINTS

Regeneron at ASH’24: Aafia Chaudhry in a Stimulating Dialogue Exchange with PharmaShots

Shots: Recently, Regeneron presented Odronextamab’s data in treating patients with different B-NHL subtypes (OLYMPIA studies) and marginal zone lymphoma (ELM-2 study) Aafia Chaudhry, Vice President, Global Program Head for Hematology-Oncology at Regeneron, discusses Odronextamab’s ongoing studies as monotherapy and in combination to treat various malignancies Aafia shares the upcoming PDUFA date on July 30th for…

BySaurabh ChaubeyJuly 2, 2025

INSIGHTS+

Top Performing Drug of 2021 – Imbruvica (January Edition)

Active Ingredient: Ibrutinib Dosage Forms & Strengths: Capsules: 70 mg and 140 mg Tablets: 140 mg, 280 mg, 420 mg, and 560 mg Mechanism of Action: Bruton's tyrosine kinase Inhibitor (BTKi) First Approval: US (13 Nov 2013), EU (Oct 2014)  Revenue Analysis Imbruvica is an oral therapy that inhibits a protein called Bruton's tyrosine kinase. Imbruvica was one…

BySenior EditorJanuary 25, 2023

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Regeneron at ASH’24: Aafia Chaudhry in a Stimulating Dialogue Exchange with PharmaShots

Top Performing Drug of 2021 – Imbruvica (January Edition)

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