Prodotti competitors / Area Oncology
European Commission approves camizestrant (Etcamah) with CDK4/6 inhibitors for ESR1-mutated ER-positive advanced breast cancer in first-line setting
The European Commission has approved AstraZeneca’s camizestrant (Etcamah) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation detected during first-line endocrine therapy and prior to disease progression.
The approval is based on results from the Phase III SERENA-6 trial, a global double-blind study evaluating a circulating tumour DNA (ctDNA)-guided treatment strategy. The trial monitored the emergence of ESR1 mutations through routine blood-based ctDNA testing and enabled an early switch from aromatase inhibitor therapy to camizestrant while maintaining the same CDK4/6 inhibitor.
At a planned interim analysis, the camizestrant combination reduced the risk of disease progression or death by 56% compared with continued aromatase inhibitor treatment plus CDK4/6 inhibition (HR 0.44; 95% CI 0.31–0.60; p<0.00001). Median progression-free survival was 16.0 months with camizestrant versus 9.2 months with standard endocrine therapy. A subsequent pre-planned analysis also demonstrated a statistically significant improvement in time to second disease progression (PFS2), with median PFS2 of 25.7 months versus 19.1 months (HR 0.63; 95% CI 0.46–0.86).
According to AstraZeneca, camizestrant is the first and only next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist approved in this first-line setting and can be combined with all widely approved CDK4/6 inhibitors. The safety profile observed in SERENA-6 was consistent with the known profiles of the individual agents, with no new safety signals identified.
Camizestrant has also been approved in Japan, the United Arab Emirates and Saudi Arabia for this indication, while regulatory reviews remain ongoing in other jurisdictions, including the United States.
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