Justify protocol amendments in detail: CDSCO Panel tells Eli Lilly on Trail of Imlunestrant
New Delhi: In response to the proposed protocol amendment for Eli Lilly's anticancer drug LY348-4356 (Imlunestrant), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to present the protocol with amendments and justification in details in an upcoming SEC meeting.
This came after the firm presented the proposed protocol amendment (a), dated 08-Oct-2021 to the protocol no. J2J-OX-JZLC (EMBER-3),before the committee.
Imlunestrant or LY348-4356 is an investigational, oral selective estrogen receptor degrader (SERD) with pure antagonistic properties. The estrogen receptor (ER) is the key therapeutic target for patients with ER+/HER2- breast cancer.
Novel degraders of ER may overcome endocrine therapy resistance while providing consistent oral pharmacology and convenience of administration. Imlunestrant was specifically designed to deliver continuous estrogen receptor target inhibition throughout the dosing period and regardless of ESR1 mutational status.
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