CALQUENCE® (acalabrutinib) granted Priority Review in the US …
WEB12 hours ago — The addition of CALQUENCE to SoC provided almost 1.5 years of additional median progression free survival (mPFS) with mPFS of 66.4 months for patients treated with the CALQUENCE combination versus ...
AstraZeneca's Calquence sNDA Gets FDA Priority Tag for …
WEB6 hours ago — In the first six months of 2024, Calquence generated sales worth $1.51 billion, up 22% year over year, driven by new patient share gains in frontline CLL worldwide.
AstraZeneca Seeks Expanded Use For Blood Cancer Drug Calquence…
WEB5 hours ago — Adding Calquence to SoC provided almost 1.5 years of additional median progression-free survival (mPFS) with mPFS of 66.4 months for patients treated with the Calquence combination versus 49.6 ...
CALQUENCE combination regimen demonstrated statistically …
WEBMay 2, 2024 — CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on …
Calquence combination regimen demonstrated statistically …
WEBMay 2, 2024 — Positive high-level results from an interim analysis of the ECHO Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus standard ...
Fixed-duration Calquence plus venetoclax, - AstraZeneca
WEBJul 29, 2024 — Positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to ...
CALQUENCE® (acalabrutinib) granted Priority Review in the US …
WEB23 hours ago — Serious adverse reactions were reported in 39% of patients in the CALQUENCE plus obinutuzumab arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (7% and 2.8% ...
FDA Grants Priority Review to Acalabrutinib in Treatment-Naive …
WEB7 hours ago — FDA. The FDA has granted priority review to the supplemental new drug application (sNDA) seeking the approval of acalabrutinib (Calquence) for patients with previously untreated mantle cell ...
CALQUENCE - Business Wire
WEBJun 16, 2024 — CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication...
CALQUENCE® (acalabrutinib) granted Priority Review in the US …
WEB12 hours ago — CALQUENCE. CALQUENCE(acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). CALQUENCE binds covalently to BTK, thereby inhibiting its activity. 10 In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.