EMA Recommends Granting a Marketing Authorisation for Glasdegib
Glasdegib, an Hedgehog inhibitor, is intended for the treatment of acute myeloid leukaemia
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Glasdegib, an Hedgehog inhibitor, is intended for the treatment of acute myeloid leukaemia
Accelerated approval is based on data from the Cohort B of Study KEYNOTE-555
Pathology analysis found enrichment of fusions after progression on endocrine therapy
Mortality rates do not appear to be associated with any specific type of treatment or comorbidity in this patient group
It was developed as a biosimilar medicine
Treatment delay of at least 2 months reported in only one quarter of patients
Approval is based on the results from the E1912 trial
Efficacy in patients with metastatic triple negative breast cancer was demonstrated in IMMU-132-01 study
An experience in New York City
Evidence for efficacy is based on the results from the HER2CLIMB trial
FDA also approved a companion diagnostic for patient selection
It is approved for patients who have symptomatic, inoperable plexiform neurofibromas
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