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Results For "BTK-inhibitor"

25 News Found

FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma
Drug Approval | February 18, 2026

FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma

The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma


Lilly drug cuts risk of disease progression or death by 80% in trial
Clinical Trials | December 11, 2025

Lilly drug cuts risk of disease progression or death by 80% in trial

The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study


FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment
Drug Approval | December 04, 2025

FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment

Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor


EU clears Bristol Myers Squibb’s CAR-T therapy Breyanzi for tough-to-treat Lymphoma
Drug Approval | November 25, 2025

EU clears Bristol Myers Squibb’s CAR-T therapy Breyanzi for tough-to-treat Lymphoma

The European Commission’s green light marks Breyanzi’s fourth indication in Europe and extends access to patients across all EU and EEA countries


AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia
News | June 07, 2025

AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia

AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations


Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


Roche’s fenebrutinib demonstrated near-complete suppression of disease activity and disability progression
Clinical Trials | September 04, 2024

Roche’s fenebrutinib demonstrated near-complete suppression of disease activity and disability progression

New Phase II data show vast majority of patients experiencing no relapses or disability progression


Tolebrutinib meets primary endpoint in HERCULES phase 3 study
Clinical Trials | September 03, 2024

Tolebrutinib meets primary endpoint in HERCULES phase 3 study

Phase 3 study results will form the basis for future discussions with global regulatory authorities


Calquence plus chemoimmunotherapy reduced the risk of disease progression or death by 27%
Clinical Trials | June 17, 2024

Calquence plus chemoimmunotherapy reduced the risk of disease progression or death by 27%

First and only BTK inhibitor to demonstrate favourable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting


AstraZeneca’s Calquence combination regimen demonstrated positive results in 1st-line mantle cell lymphoma in ECHO Phase III trial
Clinical Trials | May 08, 2024

AstraZeneca’s Calquence combination regimen demonstrated positive results in 1st-line mantle cell lymphoma in ECHO Phase III trial

First BTK inhibitor to show favourable trend in overall survival vs. standard-of-care chemoimmunotherapy in this setting