Sun Pharma Gets CDSCO Panel Nod to Manufacture, Market Enzalutamide for Prostate Cancer
New Delhi: The pharmaceutical major Sun Pharmaceutical Industries has received approval from the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organization (CDSCO), to manufacture and market Enzalutamide Tablets 40 mg, 80 mg, and 160 mg for the treatment of adult men with specific advanced prostate cancer.
Enzalutamide tablets are approved for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated and adults with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy.
This came after the drug major presented a proposal for a grant of permission to manufacture and market Enzalutamide Tablets 40 mg, 80 mg, and 160 mg for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated and adults with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy, along with a bioequivalence (BE) study report of Enzalutamide Tablets 160 mg before the committee.
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 compared to the natural ligand dihydrotestosterone.
Enzalutamide is a second-generation androgen receptor inhibitor used to treat castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
Castration-resistant prostate cancer (CRPC) is prostate cancer that continues to grow and spread despite androgen deprivation therapy (ADT), which lowers testosterone levels to a castrate state.
At the recent SEC meeting for oncology, the expert panel reviewed the proposal for a grant of permission to manufacture and market Enzalutamide Tablets 40 mg, 80 mg and 160 mg for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated and adults with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy, along with a bioequivalence (BE) study report of Enzalutamide Tablets 160 mg.
In line with the above, the committee noted that Enzalutamide Tablets 40 mg and 80 mg are approved by the USFDA/EMA for applied indication.
In addition, the expert panel noted that Enzalutamide Tablets 160 mg have also been approved in India since 2022, and the firm has performed a BE study using approved Enzalutamide Tablets 160 mg as a comparator.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Enzalutamide Tablets 40 mg, 80 mg, and 160 mg for the applied indication.
