Category: Brukinsa
Shots: The approval is based on 2 trials i.e., P-II MAGNOLIA & P-I/II BGB-3111-AU-003 trial evaluate Brukinsa (160mg, bid or 320 mg, qd) in 66 & 20 patients with R/R MZL who received at least 1 anti-CD20-based regimen Both trial demonstrated ORR (56% & 80%), CR rate (20% & 20%) based on assessment using CT […]
Shots: The approval is based on P-III ASPEN trial evaluating Brukinsa (160mg, bid, or 320 mg, qd) vs ibrutinib in 201 patients with WM who harbor an MYD88 mutation The 1EPs of the trial was VGPR rate in the overall ITT population as assessed by IRC. VGPR rate (28% vs 19%) based on the modified […]
AstraZeneca has thrown down the gauntlet to AbbVie and Johnson & Johnson with new data for Calquence in chronic lymphocytic leukaemia (CLL) that it says show a safety advantage over Imbruvica – currently dominating the BTK inhibitor market. In the ELEVATE-RR study, Calquence (acalabrutinib) matched Imbruvica (ibrutinib) when it came to keeping adults with previously […]
Shots: The P-III head-to-head APSEN trial involves assessing Brukinsa (160 mg, PO, bid) vs ibrutinib (420 mg, PO, qd) in 652 patients with r/r CLL or SLL, until disease progression or unacceptable toxicity The interim analysis of the trial met its 1EP & pre-specified 2EPs i.e superior ORR & lower risk of atrial fibrillation or […]