Shots:The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitorDesignation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…
Shots:The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regionsApproval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…
Shots:The CHMP has recommended Calquence + bendamustine & rituximab for the treatment of 1L MCL adults, who are ineligible for autologous HSCT; regulatory review is ongoing in Japan & other regionsOpinion was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed…

