CDSCO Panel Asks Astellas Pharma to Update Enzalutamide Label After Phase IV Study
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO), has opined Astellas Pharma India to update the prescribing information of Enzalutamide 40 mg soft capsule after reviewing the results of a Phase IV clinical study.
This came after Astellas Pharma India presented Phase IV clinical trial report of Enzalutamide 40 mg soft Capsule along with the Serious Adverse Event (SAEs) reported, before the committee.
Firm presented study objective, study design, study endpoints, Inclusion and Exclusion criteria, safety assessment, demographic & baseline characteristics, study population, efficacy results, safety results TEAEs reported during study, Drug related Serious Treatment-Emergent Adverse Events (TEAEs) etc.
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Enzalutamide is a competitive androgen receptor (AR) inhibitor that has a threefold inhibition on the androgen signaling pathway without significant AR agonist activity. It inhibits androgen binding to its receptor, androgen receptor nuclear translocation, and subsequent interaction with chromosomal DNA to upregulate oncogenes. Enzalutamide binds to the AR with 5- to 8-fold greater affinity than first-generation antiandrogens such as bicalutamide and only 2- to 3-fold reduced affinity than the natural ligand dihydrotestosterone.
After detailed deliberation, the committee considered the results of the Phase IV clinical study and recommended that the firm should update the phase IV study and SAEs outcome in the prescribing information and the revised prescribing information should be submitted to CDSCO within one month for further review by the committee.
