Relapsed Or Refractory Mantle Cell Lymphoma
May 25, 2026
BeOne Enters the BCL-2 Arena: Can BEQALZI Disrupt VENCLEXTA’s Longstanding Dominance?
Summary BeOne Medicines received accelerated approval for sonrotoclax (BEQALZI) to treat adults with relapsed or refractory mantle cell lymphoma (MCL) who have failed at least two prior therapies, including a BTK inhibitor. Backed by Phase 1/2 trial data in 103 heavily pre-treated patients, the drug distingu...
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Oct 14, 2025
FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade; Denali Therapeutics’ Tividenofusp Alfa BLA Review for Hunter Syndrome Extended by FDA; Bicara’s Ficerafusp Alfa Earns FDA Breakthrough Tag for 1L HPV-Negative Head & Neck Cancer; BeOne Medicines’ Sonrotoclax Granted FDA Breakthrough Designation for Cancer Treatment; FDA Clears LIBTAYO for Adjuvant Use in Cutaneous Squamous Cell Carcinoma
FDA Approves Boehringer’s JASCAYD as First New IPF Therapy in Over a Decade Boehringer Ingelheim’s JASCAYD (nerandomilast) has received FDA approval as an oral treatment for adults with idiopathic pulmonary fibrosis (IPF), marking the first new therapy for the condition in over a decade. JASCAYD is the first and...
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Dec 13, 2021
CAR-T Cell Therapy aka Miraculous Technology: Mapping the Market, Approved Therapies, Competitive Landscape and Impact of COVID-19
Chimeric antigen receptor T-cell (CAR T) therapies are shown to have transformative potential as a new type of cancer treatment that utilizes the immune system to fight the disease. It involves the process where genetically engineered T cells (patient/donor) express a chimeric antigen receptor to target a specific ...
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Jun 09, 2020
Alnylam’s lumasiran results; AZ’s oncology drug; Astellas Roxadustat; Evotec’s partnership with ABL
Alnylam Pharmaceuticals has released the Phase III results of the clinical trial ILLUMINATE-A evaluating lumasiran for Primary Hyperoxaluria Type 1 Primary Hyperoxaluria Type 1 (PH1) is a rare disorder that affects kidneys due to an excess buildup of oxalate, which in normal cases is filtered through the kidneys...
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Feb 11, 2020
Good news for Kite’s KTE-X19, and Aquestive’s Libervant; and a commercialization deal between ReForm Biologics, MilliporeSigma
FDA has accepted Biological License Application submitted by Kite for its CAR-T cell therapy- KTE-X19, for relapsed or refractory mantle cell lymphoma (MCL) The drug- KTE-X19, which is an investigational chimeric antigen receptor (CAR) T cell therapy treatment method for curing relapsed or refractory mantle cell...
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