The FDA approved capivasertib, in combination with fulvestrant, for the treatment of patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer, according to a press release issued by the agency.

The treatment is approved for patients with one or more alterations in PIK3CA, AKT1, or PTEN, as detected by an FDA-approved diagnostic test. It should be offered to patients who experience progression in the metastatic setting after one or more endocrine therapy, as well as patients who develop recurrence within 12 months of completing adjuvant therapy. The FDA also approved a companion diagnostic, the FoundationOne CDx assay, as a diagnostic tool to identify appropriate patients for the therapy.

“The prevalence of HR-positive breast cancer means the introduction of new targeted treatment options for this patient population will have an exponential impact,” said Shehzin Tietjen, associate director of corporate relations for Living Beyond Breast Cancer, in a press release issued by Foundation Medicine. “Biomarker testing is such an important component of getting patients on the right therapy for their specific cancer, and we’re encouraged to see additional companion diagnostic indications being approved to help increase patient access to precision medicine.”

The FDA based its decision on results of the phase 3 CAPItello-291 study, which were published in The New England Journal of Medicine. Compared to placebo, treatment with capivasertib plus fulvestrant significantly improved progression-free survival in the overall population (median, 7.2 months vs. 3.6 months; P < .001), as well as in patients with confirmed AKT pathway alterations (median, 7.3 months vs 3.1 months; P < .001).

Capivasertib was approved at a recommended twice-daily dose of 400 mg every 4 days, followed by 3 days off, until disease progression or intolerable toxicity.

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Disclosures: CAPItello-291 is being supported by AstraZeneca.

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