The FDA’s decision allows patients with relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome — types of blood cancer — to continue enrolling on the TakeAim Leukemia trial.
The Food and Drug Administration (FDA) lifted its partial clinical hold on the phase 1a portion of the TakeAim Leukemia clinical trial.
Patients can now enroll onto the trial, which is evaluating emavusertib in patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndrome, which are types of blood cancer.
The agency originally placed partial clinical holds on TakeAim Leukemia and TakeAim Lymphoma in April, which prevented the drug developer from recruiting and enrolling patients onto the trial until more information was submitted to the FDA regarding emavusertib’s safety and efficacy.
In particular, the FDA requested information on rhabdomyolysis, a potentially fatal condition where damaged muscle breaks down, causing muscle cell contents to enter the bloodstream. Earlier in August, the FDA lifted the hold on TakeAim Lymphoma.
The FDA reviewed data on rhabdomyolysis risk caused by emavusertib, and assessed the manufacturer’s plans on how to identify the condition and manage it, if detected.
"We are pleased to announce the results of the FDA's review and to have addressed potential concerns about the identification and management of rhabdomyolysis," James Dentzer, president and CEO of Curis, the manufacturer of emavusertib, said in a press release. "We are working with our clinical sites to quickly resume enrollment of additional patients."
Now, the FDA has OK’d enrollment of additional patients onto the phase 1a portion of TakeAim Leukemia, which is evaluating emavusertib as a single agent. This stage of the trial is meant to find the proper dosage of the drug. Curis agreed to enroll at least nine additional patients who will receive 200 milligrams (mg) of the drug.
The phase 1b part of the trial will evaluate emavusertib in combination with Vidaza (azacytidine) or Venclexta (venetoclax). Then phase 2a will include current study participants who benefit from the treatment and will continue to be treated with twice-daily emavusertib at 300 mg or lower. However, phases 1b and 2a are still under partial clinical hold by the FDA, which will review data from the first part of the trial and then decision on the continuation.
Curis updated its timeline for the trial, and now expect to have preliminary data from the TakeAim Leukemia trial available in 2023.
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