Eli Lilly gets CDSCO panel nod to study anticancer drug Imlunestrant
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...
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.
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