CDSCO Panel Approves Roche's Protocol Amendment Proposal for Anticancer Drug Giredestrant
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Roche's protocol amendment proposal for the clinical study to assess the safety and efficacy of the anticancer drug Giredestrant.
This came after the drug major Roche presented protocol amendment version 3 dated 18 November 2022 and protocol amendment version 4 dated 28 June 2023, protocol No. WO43571.
The above study is to evaluate the efficacy and safety of Giredestrant in combination with phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) versus phesgo in participants with locally advanced or metastatic breast cancer (heredERA Breast Cancer).
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.
Giredestrant is an orally available selective estrogen receptor degrader/downregulator (SERD), with potential antineoplastic activity. Upon oral administration, giredestrant specifically targets and binds to the estrogen receptor (ER) and induces a conformational change that promotes ER degradation.
Giredestrant works by blocking this receptor to prevent the action of oestrogen, and in the process causes the receptor to be degraded. This investigational medicine has also shown efficacy regardless of ESR1 mutation status (mutations in the ESR1 gene are important mechanisms of resistance to hormone therapy).
Giredestrant is a type of study medicine known as “hormone therapy” or “endocrine therapy”. Giredestrant is also known as a “SERD”, which stands for “selective estrogen receptor degraders”. Giredestrant may be useful for patients with ER+ breast cancer.
At the recent SEC meeting for Oncology held on the 9th and 10th of January 2024, the expert panel reviewed the proposal presented by the drug major Roche for protocol amendment version 3 dated 18 November 2022 and protocol amendment version 4 dated 28 June 2023, protocol No. WO43571.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
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