Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that ER positive, ESR1 activating variants, and HER2-negative status confers therapeutic sensitivity to Abemaciclib, Camizestrant in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1-mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor. The Product information further states that in pre- or perimenopausal women and in men, camizestrant plus a CDK4/6 inhibitor should be combined with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist.
This statement is based on a regulatory approval from the European Medicines Agency:
Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1-mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor.