The drug is the second cardiac myosin inhibitor to get regulatory signoff in the United States, following mavacamten in 2022.
BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients INDIANAPOLIS, July 29, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: ...
In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine ...
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New Drug Approved for Hypertrophic Cardiomyopathy
"HCM is a heart muscle disease associated with a significant symptom burden. This approval of a new drug, Myqorzo, represents ...
Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with a covalent BTK inhibitor This expanded ...
FDA approved CYTK's Myqorzo for oHCM. It reduces heart's pumping ability, has a warning for heart failure and expected to ...
Pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05 Progression-free survival data was immature, but trending ...
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