CDSCO Panel Grants Roche's Protocol Amendment Proposal For Anti-cancer Drug Giredestrant
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment of the drug major Roche's clinical study titled "A study evaluating the efficacy and safety of adjuvant Giredestrant compared with Physician's choice endocrine monotherapy in participants with estrogen receptor-positive, HER2- Negative early breast cancer".
This came after the drug major Roche presented protocol amendment version 5.0 dated 25 August 2023 protocol No. GO42784. This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.
In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.
Giredestrant is an orally available selective estrogen receptor degrader/downregulator (SERD), with potential antineoplastic activity. Giredestrant induces an inactive conformation to the ER LBD, as measured by displacement of co-activator peptides.
Anastrozole is a type of hormone treatment. It works by lowering the levels of estrogen hormones in your body. It is mainly prescribed for women who have been through menopause and have a type of cancer called hormone-dependent breast cancer.
Exemestane is used to treat early and advanced breast cancer in women who have already stopped menstruating (postmenopausal). It is usually used in women who have already received a cancer medication called tamoxifen. Many breast cancer tumors grow in response to estrogen.
Letrozole is a medication that comes in tablet form. treats some types of breast cancer by decreasing the amount of estrogen hormone your body makes. This can slow or stop breast cancer cells from growing and spreading.
Tamoxifen is a selective estrogen receptor modulator (SERM) medication used to treat breast cancer in men and women and as a prophylactic agent against breast cancer in women.
At the recent SEC meeting for Oncology held on 7th and 8th February 2023, the expert panel reviewed the protocol amendment version 5.0 dated 25 August 2023 protocol No. GO42784.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
