Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Giredestrant for Breast Cancer
New Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of the anti-cancer drug Giredestrant compared with Fulvestrant, Palbociclib, Ribociclib, Abemaciclib.
This came after the drug major Roche presented Phase III clinical trial protocol No. CO44657.
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
Giredestrant, an investigational small molecule, is a full ER antagonist belonging to the selective estrogen receptor degrader class of therapeutics.
Giredestrant induces an inactive conformation to the ER LBD, as measured by displacement of co-activator peptides. In addition to its direct antagonist properties, the mechanism of action of giredestrant includes reducing levels of ER protein through proteasome-mediated degradation.
Fulvestrant is an estrogen receptor antagonist used to treat HR+ breast cancer that may also be HER2-.Fulvestrant is used in the management and treatment of advanced breast cancer. It is a selective estrogen receptor degrader. This activity outlines the indications, action, and contraindications for fulvestrant as a valuable agent in the treatment of advanced breast carcinoma.
Palbociclib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply.
At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the Phase III clinical trial protocol No. CO44657.
After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as presented by the firm.
