Bayer Pharma Gets CDSCO Panel Nod To Update Prescribing Information of Anti-cancer Drug Darolutamide

This came after the firm presented the proposal for updated prescribing information for Darolutamide 300 mg film-coated tablets (Nubeqa), changes version 4 to 5 (version No NU_2023_02 dated 24 Feb 2023 based on the updated company core data sheet (CCDS).

Darolutamide is an androgen receptor antagonist used for castration-resistant, non-metastatic prostate cancer, and metastatic hormone-sensitive prostate cancer.

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. Its main metabolite, keto-darolutamide, shows similar pharmacological activity to the parent drug, darolutamide.

Darolutamide has been found to bind more tightly to the AR receptor than apalutamide and enzalutamide, which are other androgen receptor antagonists.

Darolutamide is indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

At the recent SEC meeting for Oncology and Hematology held on 8th June 2023, the expert panel reviewed the proposal for updating the prescription information for the Darolutamide 300 mg film-coated tablets (Nubeqa), changes version 4 to 5 (version No NU_2023_02 dated 24 Feb 2023 based on the updated company core data sheet (CCDS).

After detailed deliberation, the committee recommended the grant of approval for the proposed update in prescribing information as presented by the firm.

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