Intas Pharma gest CDSCO panel nod to manufacture, market anticancer drug Enzalutamide tablet
New Delhi: Intas Pharma has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market Enzalutamide Tablet 80 mg.
However, this nod is subject to the condition that the firm should conduct a Phase IV clinical trial.
This came after the drug maker Intas pharma presented the proposal for grant of permission to manufacture and market Enzalutamide Tablet 80 mg along with bioequivalence (BE) study reports in fasting and fed conditions.
Intas Pharma has informed that Enzalutamide capsules 80 mg are approved in India (Year 2020), and Enzalutamide tablet 80 mg is also approved in the US (Year 2020) and in Europe (Year 2013).
Enzalutamide is a second-generation androgen receptor inhibitor used to treat castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
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 2-3 fold reduced affinity than the natural ligand dihydrotestosterone.
At the recent SEC meeting for Onchology, the expert panel reviewed the proposal to manufacture and market Enzalutamide Tablet 80 mg along with bioequivalence (BE) study reports in fasting and fed conditions.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Enzalutamide Tablet 80 mg for the proposed indication, subject to the condition that the firm should conduct a phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit Phase IV clinical trial protocol within 3 months from the date of approval of the drug to CDSCO for further review by the committee.
