AstraZeneca Gets CDSCO Panel Nod to Import, Market Camizestrant for Breast Cancer

New Delhi: Citing an unmet medical need, the Subject Experts Committee (SEC) has granted permission to AstraZeneca Pharma India Limited to import and market Camizestrant film-coated tablets 75 mg for the indication of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon emergence of ESR1 mutation, along with a waiver of the local Phase III clinical trial, subject to conditions.

The committee stated that the drug should be sold by retail under the prescription of a medical oncologist only. Further, it stated that the firm should conduct a Phase IV clinical trial and submit the Phase IV Clinical Trial protocol within 3 months of approval of the drug to CDSCO for further review by the committee.

This came after the firm presented the proposal for the grant of permission for the import and marketing of Camizestrant film-coated tablets 75 mg, along with justification for the local Phase III clinical trial waiver before the committee.

Camizestrant is an oral selective estrogen receptor degrader (SERD) and estrogen receptor antagonist. It binds to the ligand binding domain of ERα, antagonizing the activity of ERα encoded by both wild-type ESR1 and mutated ESR1, and induces proteasome-dependent degradation of ERα without agonizing ERα.

Camizestrant has demonstrated anti-tumor activity in ER-positive cell lines and patient-derived xenograft models, including those with wild-type or mutated ESR1, and the combination of camizestrant with a CDK4/6 inhibitor showed greater anti-tumor activity than either agent alone in these models.

After detailed deliberation, the committee noted that Camizestrant had been approved in the USA, European Union, United Arab Emirates, Saudi Arabia and other countries.

Further, the committee noted that this is unmet medical need and recommended for phase III CT waiver for the indication hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative, locally advanced or metastatic breast cancer upon emergence of ESR1 mutation.

Accordingly, the SEC recommended granting permission to import and market Camizestrant film-coated tablets 75 mg, subject to the following conditions:

1) The drug should be sold by retail under the prescription of a medical oncologist only.

2) The firm should conduct a Phase IV clinical trial and submit the Phase IV Clinical Trial protocol within 3 months of approval of the drug to CDSCO for further review by the committee.