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The U.S. Food and Drug Administration (FDA) has granted accelerated approval to camizestrant (Etcamah) for some adults with advanced hormone receptor (HR)-positive, HER2-negative metastatic or locally advanced breast cancer with ESR1 mutations. Etcamah is indicated to be used in combination with a CDK4/6 inhibitor.
Etcamah joins other hormone therapies for breast cancer. Etcamah can be started as soon as an ESR1 mutation is detected — before scans show that the cancer has progressed.
Etcamah gives oncologists another treatment option to consider when testing suggests that breast cancer is becoming resistant to a different class of hormone therapy, aromatase inhibitors.
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Because Etcamah received accelerated approval, the FDA is requiring additional studies to confirm its benefit.
Etcamah is an estrogen receptor antagonist. It may be recommended for people who develop an ESR1 mutation while taking an aromatase inhibitor and a CDK4/6 inhibitor, abemaciclib, palbociclib, or ribociclib.
Aromatase inhibitors work by lowering estrogen levels. However, some breast cancers develop changes in a gene called ESR1 during treatment. These mutations can keep estrogen receptors active even when estrogen levels are low, making aromatase inhibitors less effective.
Etcamah binds to estrogen receptors, including mutated receptors, blocks their activity, and promotes their breakdown. This can help slow the growth of cancer.
Etcamah is typically taken orally once daily, with or without food.
The FDA based its approval on results from SERENA-6, a phase 3 trial of 315 people whose HR-positive, HER2-negative advanced breast cancer developed an ESR1 mutation while they were taking an aromatase inhibitor plus a CDK4/6 inhibitor.
Participants either switched from the aromatase inhibitor to Etcamah while continuing the same CDK4/6 inhibitor or continued their existing treatment.
Median progression-free survival — the time before cancer grew, spread, or worsened — was 16 months with Etcamah and a CDK4/6 inhibitor, compared with 9.2 months with an aromatase inhibitor and a CDK4/6 inhibitor.
Overall survival data was not yet available when the FDA reviewed the results.
As with any treatment, Etcamah may cause side effects.
Common side effects and laboratory changes include:
The prescribing information includes a boxed warning for the risk of irregular heart rhythm when the drug is taken together with certain other medications.
Always discuss potential side effects with your healthcare provider when considering a new treatment.
Etcamah adds another treatment option for people with HR-positive, HER2-negative advanced breast cancer that develops an ESR1 mutation. More notably, it gives oncologists an FDA-approved option to change treatment when the mutation appears, rather than waiting for the cancer to progress on scans.
More research is needed to determine whether changing treatment at this earlier point improves long-term outcomes. If your current breast cancer treatment isn’t meeting your needs, talk with your oncology team about whether newer treatment or testing options may be appropriate for you.
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