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Will results revive ibrutinib role in MCL following withdrawal of accelerated approval?

High survival rates observed in patients not normally suitable for transplant

24 weeks of daily treatment significantly reduced recurrent nosebleeds in HHT trial

Adding anti-CD38 antibodies boosts response and PFS, but timing, sequencing, cost questioned

Investigational drug revumenib now under review at FDA for KMT2A-rearranged disease

Marstacimab reduced the annualized bleeding rate versus on-demand, prophylactic treatments

Combos with navitoclax or pelabresib led to more patients achieving reductions

Highest overall response rate and least toxicity seen with lowest dose

No advantage for MRD-negative patients in first remission after induction, regardless of FLT3 ITD

Better 2-year PFS, OS, but not applicable to primary refractory disease

Time-limited approach based on MRD response outperforms FCR, but U.S. applicability unclear

More than half of children in study had no treated bleeds at follow-up of more than 100 weeks

Near complete resolution of pain events in patients, including adolescents

Survival 75% worse compared with outcomes seen in registrational studies