CDSCO panel wants justification on Protocol Amendments on Trail of Imlunestrant

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

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CDSCO Panel Expert Committee
CDSCO Panel Expert Committee

Last Updated on December 31, 2023 by The Health Master

The Subject Expert Committee (SEC) operating under the Central Drug Standard Control Organization (CDSCO) has advised the company to present the protocol with amendments and justification in detail at a future SEC meeting in response to the proposed protocol amendment for Eli Lilly’s anticancer drug LY348-4356 (Imlunestrant).

The firm had previously presented the committee with a proposed protocol amendment (a), dated 08-Oct-2021, to protocol no. J2J-OX-JZLC (EMBER-3).

A selective estrogen receptor degrader (SERD) under investigation with only antagonistic properties is called imlunestrant, also known as LY348-4356. 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 created specifically to deliver continuous estrogen receptor target inhibition over the course of dosing and regardless of the presence of ESR1 mutations.

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

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 is the goal of the Phase 3 Randomized, Open-Label Study known as EMBER-3 (J2J-OX-JZLC).

The main goal of this study is to evaluate the efficacy of imlunestrant in comparison to conventional hormone therapy and the efficacy of imlunestrant with abemaciclib in comparison to imlunestrant in patients with estrogen receptor-positive (ER+) and human epidermal receptor 2 negatives (HER2-) breast cancer.

The expert panel at the most recent SEC meeting for oncology and hematology held on August 5, 2002, reviewed the protocol amendment to protocol no. J2J-OX-JZLC (EMBER-3) presented by the pharmaceutical giant Eli Lilly, dated 08-Oct-2021.

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

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