The FDA expanded approval of the drug, acalabrutinib, to include previously untreated MCL in adults who are also ineligible for a hematopoietic stem cell transplant that is a treatment option for ...
An international study published in the New England Journal of Medicine provides hope for chronic lymphocytic leukemia (CLL) ...
2 In combination, the application for acalabrutinib previously received priority review—which shortens the FDA’s review period from 10 to 6 months—and orphan drug designations, meaning there ...
Estimated 36-month progression-free survival at a median follow-up of 40.8 months was 76.5% with acalabrutinib–venetoclax, 83.1% with acalabrutinib–venetoclax–obinutuzumab, and 66.5% with ...
Dr. Tycel Phillips discusses the FDA approval of a Calquence combo in MCL, making it the first and only BTK inhibitor ...
January 17, 2025--(BUSINESS WIRE)--AstraZeneca’s CALQUENCE ® (acalabrutinib ... The approval was granted by the Food and Drug Administration (FDA) after securing Priority Review.
January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.
Findings showed acalabrutinib with bendamustine and rituximab (BR) reduced the risk of disease progression or death by 27% compared with placebo plus BR. The Food and Drug Administration (FDA ...
During a Case-Based Roundtable® event, Nakhle Saba, MD, and participants discussed the data supporting the 2 newer BTK ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
An international study of over 800 chronic lymphocytic leukemia (CLL) patients found that an all-tablet therapy of ...
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