Bayer Gets CDSCO Committee Nod to Manufacture, Market Darolutamide 300 mg for mHSPC, PMS Study Mandated
New Delhi: Bayer Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) to manufacture and market Darolutamide film-coated tablets 300 mg for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
However, this nod is subject to the condition that the firm should conduct an active post-marketing surveillance (PMS) study in at least 200 patients and accordingly, it should submit an active PMS study protocol to CDSCO within three months from the date of approval of the drug.
This came after the drug maker presented their proposal for a grant of permission to manufacture and market Darolutamide Film-Coated Tablets 300 mg for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
In addition, the firm has informed that they have already received approval for the proposed indication in the USA, the UK, and Europe.
Darolutamide is an androgen receptor antagonist used for castration-resistant, non-metastatic prostate cancer and metastatic hormone-sensitive prostate cancer. The actions of androgens on androgen receptors (AR) potentiate the growth and survival of prostate cancer cells.
Darolutamide competitively inhibits androgens from binding to their receptors, inhibiting AR nuclear translocation as well as AR-mediated transcription. The end result of these processes is a decrease in prostate cancer cell proliferation and tumor size.
At the recent SEC meeting for oncology held on 6th August, 2025, the expert panel reviewed the proposal presented by Bayer Pharmaceuticals to manufacture and market Darolutamide film-coated tablets 300 mg for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
After detailed deliberation, the committee recommended for the grant of permission to manufacture and market Darolutamide Film-Coated Tablets 300 mg for the proposed indication subject to the condition that the firm should conduct an Active PMS Study in at least 200 patients.
Accordingly, the expert panel suggested that the firm should submit the Active PMS Study protocol to CDSCO within three months from the date of approval of the drug.
