FDA based its Rezurock approval on data from an open-label trial called ROCKstar that enrolled 65 patients who had previously tried between two and five different treatments.
At median, study patients had cycled through three previous lines of therapy before trying Rezurock. After seven cycles of treatment, 75% of patients had responded. After a year’s followup, 62% of those who responded still didn’t need systemic therapy.
The FDA approval, which applies to patients who’ve tried at least two different drug treatments
NCCN AML 2021
Rezurock Prescribing Information 2021
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