The Subject Expert Committee (Oncology), in its 25th meeting held at CDSCO headquarters, has recommended granting permission to Bayer Pharmaceuticals Pvt. Ltd. for the manufacture and marketing of Darolutamide Film-Coated Tablets 300 mg in India.
Darolutamide, marketed globally under the brand name Nubeqa, is an antiandrogen medication used in the treatment of advanced forms of prostate cancer, including non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC/mHSPC). The drug works by blocking androgen receptors on cancer cells, thereby preventing their growth and multiplication.
The firm presented their proposal for grant of permission to manufacture and marketing of Darolutamide Film Coated Tablets 300 mg for the treatment of patients with metastatic hormone sensitive prostate cancer (mHSPC). The firm has informed to SEC that they have already received approval for the proposed indication in USA, U.K and Europe.
After detailed deliberation, the committee recommended for grant of permission to manufacture and marketing of Darolutamide Film Coated Tablets 300 mg for the proposed indication subject to condition that the firm should conduct Active PMS Study in at least 200 patients. Accordingly, the firm should submit Active PMS Study protocol to CDSCO within three months from date of approval of the drug.
