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Association details:
Biomarker:No biomarker
Cancer:Acute Myelogenous Leukemia
Drug:zelenirstat (PCLX-001) (NMT inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

Pacylex Granted FDA Fast Track Designation for PCLX-001 for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Published date:
11/22/2022
Excerpt:
Pacylex...today announced that the U.S. Food and Drug Administration (FDA) has granted PCLX-001 Fast Track Designation for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML)....The FDA’s decision was informed by the results of Pacylex’s nonclinical studies and an ongoing Phase 1/2 clinical study of PCLX-001 in non-Hodgkin Lymphoma (NHL) and solid tumor patients, which showed that treatment with PCLX-001 had a favorable safety and tolerability profile.