FDA Grants Capivasertib Plus Faslodex Priority Review for Breast Cancer

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The application for capivasertib plus Faslodex in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer has also been granted priority review, meaning that the FDA has six months to make a decision.

The Food and Drug Administration (FDA) accepted the new drug application and granted priority review for capivasertib with Faslodex (fulvestrant) for the treatment of adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer after recurrence or progression on an endocrine-based regimen.

A new drug application refers to a filing by a pharmaceutical company — AstraZeneca, in this case — which proposes that the FDA approve a drug for use in the United States, according to the Agency’s website. In addition, if priority review is granted, the FDA has six months to decide whether the therapy should be approved. Priority reviews are often granted for therapies that may provide significant improvements in the effectiveness or safety of the treatment of patients with serious conditions.

“This priority review decision underscores the potential of capivasertib to extend the effectiveness of endocrine-based treatment approaches for patients with HR-positive breast cancer who experience tumor progression on, or resistance to these widely used therapies,” Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, said in a press release from the company. “We look forward to working with the FDA to bring this potential first-in-class AKT inhibitor to patients as quickly as possible.”

Information included in the new drug application includes findings from the phase 3 CAPItello-291 trial, according to the release. Findings from the trial demonstrated that capivasertib plus Faslodex led to a 40% reduction in the risk for disease progression or death compared with placebo plus Faslodex. The median progression-free survival (the time during and after treatment when a patient with cancer is alive without disease worsening) for patients assigned capivasertib plus Faslodex was 7.2 months versus 3.6 months in those assigned placebo plus Faslodex.

The release noted that it is too early in the CAPItello-291 trial to determine whether capivasertib plus Faslodex provides an overall survival (the time when a patient with cancer is still alive) benefit, although early findings are “encouraging.”

Side effects that occurred with the capivasertib-Faslodex combination were similar to those observed in previous trials. According to the published findings in The New England Journal of Medicine, the most common side effects with capivasertib and Faslodex were rash and diarrhea. The rate of discontinuing the combination therapy as a result of side effects was “relatively low.”

The FDA has until the fourth quarter of 2023 to make a decision on capivasertib, according to the release.

HR-positive breast cancer, which is the most common subtype of the disease, affects approximately 65% of patients with breast cancer, according to the release. Patients with advanced disease may become resistant to CDK4/6 inhibitors and endocrine therapies, although treatment options after that occurs are limited. The current standard of care for patients who become resistant to those therapies is chemotherapy. Thirty percent of patients with HR-positive breast cancer that no longer responds to endocrine therapies or CDK4/6 inhibitors are anticipated to live beyond five years after receiving a diagnosis.

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FDA on blue background

The Food and Drug Administration accepted the new drug application and granted priority review for capivasertib with Faslodex for the treatment of adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer.

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