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The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended granting marketing authorization for Etcamah (AstraZeneca), a next-generation oral selective estrogen receptor degrader (SERD), for advanced breast cancer.
The active substance in Etcamah is camizestrant, an anti-estrogen endocrine therapy and complete ER antagonist. It is designed to treat 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. It works by blocking the activity of ER alpha, encoded by both wild-type and mutated ESR1, and inducing its proteasome-dependent degradation.
The positive opinion comes after the US FDA panel last month voted against the treatment, raising concerns about the trial design, not the drug’s safety or effectiveness.
Results from an interim analysis of the SERENA-6 phase 3 trial, published in the New England Journal of Medicine, found that patients with ER-positive, HER2-negative advanced breast cancer with an ESR1 mutation that emerged during treatment who were switched to camizestrant with continuation of a CDK4/6 inhibitor during first-line therapy had significantly longer progression-free survival than those who maintained the aromatase-inhibitor combination.
Of the 315 eligible patients, 157 were assigned to switch to camizestrant, while 158 continued to receive an aromatase inhibitor. Median progression-free survival was 16 months for patients who switched to camizestrant combination vs 9.2 months in the other group. Almost one-third of patients in the camizestrant arm showed sustained
disease control at 24 months of treatment vs 5.4% patients in the other arm.
In a statement, François-Clément Bidard, MD, PhD, professor of medical oncology at Institut Curie and Versailles University, France, and co-principal investigator for the SERENA-6 trial, said, “This recommendation represents an important step forward for patients with advanced breast cancer in Europe and a milestone in the adoption of new treatment strategies. There is a need for new treatments that delay disease progression in the first-line setting, after which the cancer becomes harder to treat, and a patient’s quality of life may decline. Through prompt intervention with the camizestrant combination to treat emergence of resistance before it causes disease progression and deterioration of quality of life, we are able to extend the benefit of first-line treatment and optimize outcomes.”
Etcamah will be available as 75 mg film-coated tablets. Its most common side effects in combination with a CD4/6 inhibitor include neutropenia, visual effects, infections, anemia, diarrhea, nausea, fatigue, bradycardia, and leukopenia.
In pre- or peri-menopausal women and in men, Etcamah plus a CDK4/6 inhibitor should be combined with a luteinizing hormone releasing hormone agonist or antagonist.
Detailed recommendations for its use will be published in all official European Union languages after the marketing authorization has been granted by the European Commission.
