New Delhi: The drug major, Eli Lilly has got approval from the Subject Expert Committee (SEC) functional under the Central Standard Drug Control Organisation (CDSCO) for the proposed study protocol no. J2J-MC-JZLH dated 15-Jun2022 regarding the anticancer drug Imlunestrant vs standard adjuvant.
The approval is conditional on the firm regularly monitoring adverse events, particularly those related to skeletons, and submitting such safety reports to SEC/CDSCO for assessment on an annual basis.
This came after the firm presented the proposed study protocol no. J2J-MC-JZLH dated 15-Jun-2022 before the Committee.
Imlunestrant is a small molecule, selective estrogen receptor degrader (SERD), being developed by Eli Lilly and Company, for the treatment of her2 negative breast cancer.
Imlunestrant, an orally available selective estrogen receptor degrader (SERD), with potential antineoplastic activity. Upon oral administration, imlunestrant specifically targets and binds to the estrogen receptor (ER) and induces a conformational change that results in ER degradation. This prevents ER-mediated signalling and inhibits both the growth and survival of ER-expressing cancer cells
SERDs directly induce estrogen receptor degradation, thereby eliminating the estrogen growth signal in estrogen receptor-dependent tumours, but without the development of ligand-independent resistance. Clinical development is underway in multiple countries.
At the recent SEC meeting for Oncology and Hematology held on 19th January 2023, the expert panel reviewed the proposed study protocol no. J2J-MC-JZLH dated 15-Jun-2022 before the Committee.
After detailed deliberation, the committee recommended the grant of permission to conduct the proposed study with the following conditions:
1) The firm should actively monitor the adverse events specifically the skeleton-related AEs and submit such safety reports to SEC/CDSCO for review on a yearly basis.
2) SAEs irrespective of their cause (i.e. PD) must be reported to CDSCO as per provisions of the New Drugs & Clinical Trial Rules, 2019
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