Justify protocol amendments in detail: CDSCO Panel tells Eli Lilly on Trail of Imlunestrant

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.

Imlunestrant is currently being studied in clinical trials. Safety and efficacy have not been established for the uses being studied.

EMBER-3 (J2J-OX-JZLC) is a Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant plus Abemaciclib in Patients with Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated with Endocrine Therapy.

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib works compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-).

At the recent SEC meeting for oncology and haematology held on August 5, 2002, the expert panel reviewed the protocol amendment dated 08-Oct-2021 to protocol no.J2J-OX-JZLC(EMBER-3) presented by the drug major Eli Lilly.

After detailed deliberation, the committee opined that the firm should present the protocol with amendments with justification in details in upcoming SEC.