Shots: The P-III APSEN study involve assessing of Brukinsa (zanubrutinib) vs AbbVie’s Imbruvica (ibrutinib) in 229 patients with r/r or TN WM across 61 centers in the US, EU and Australia The P-III APSEN study resulted in not meeting its 1EPs, i.e, superiority in CR & VGPR rate in up to 3yrs.; in r/r patients […]Read More
Shots: The US FDA’s accelerated approval is based on P-II BGB-3111-206 and P-I/II BGB-3111-AU-003 studies assessing Brukinsa in patients with relapsed or refractory (R/R) MCL The P-II BGB-3111-206 & P-I/II BGB-3111-AU-003 studies result: ORR (84% & 84%); CR (59% & 22%, FDG-PET scan required & not required); PR (24% & 62%); DOR (19.5 & 18.5 […]Read More
Shots: The BT designation follows the P-II trial assessing Zanubrutinib in patients with 1L mantle cell lymphoma Beigene’s Zanubrutinib is being evaluated globally in seven P-III trials in multiple areas including one for patients with waldenstrom macroglobulinemia (WM) with zanubrutinib vs ibrutinib and P-II for r/r follicular lymphoma in combination with Gazyva (obinutuzumab) Zanubrutinib (BGB-3111) […]Read More
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