FDA approves new breast cancer treatments

The U.S. Food and Drug Administration (FDA) has issued new approvals for treatments targeting advanced or metastatic breast cancer.

AstraZeneca’s Etcamah (camizestrant) has been approved as an oral therapeutic option for adult patients with hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer. This treatment is specifically indicated for those with an ESR1 gene mutation following first-line endocrine therapy and a CDK4/6 inhibitor, provided there is no disease progression. Etcamah belongs to a new class of drugs known as selective estrogen receptor degraders (SERDs), which work by blocking hormonal signals that promote tumor growth.

Additionally, the FDA approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for patients with HR+ and HER2-positive breast cancer. This approval follows the Phase III PATINA trial, which indicated that adding palbociclib to standard maintenance therapy significantly extends progression-free survival, reducing the risk of disease progression or death by 24% compared to standard treatment alone.