AstraZeneca’s Etcamah has received a positive opinion in the European Union for the treatment of adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation. The recommendation covers Etcamah, also known as camizestrant, in combination with a CDK4/6 inhibitor.
According to the European Medicines Agency, Etcamah is a selective estrogen receptor degrader and complete estrogen receptor antagonist that blocks the activity of both wild-type and mutated ESR1. The agency said the medicine’s benefit in combination with a CDK4/6 inhibitor is improved progression-free survival when patients are switched to camizestrant after detection of an ESR1 mutation while on first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor, compared with continuing the same regimen.
The full indication is for adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of an ESR1 mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor. The regulator said Etcamah should be used with palbociclib, ribociclib, or abemaciclib, and that in pre- or peri-menopausal women and in men, the combination should also include an LHRH agonist or antagonist.
The EMA said the most common side effects include neutropenia, visual effects, infections, anemia, diarrhea, nausea, fatigue, bradycardia, and leukopenia. Treatment should be initiated and supervised by a physician experienced in anticancer medicines.
Detailed recommendations will appear in the product’s summary of characteristics after the European Commission grants marketing authorization.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!