The latest development in breast cancer treatment brings hope and progress. On November 16, 2023, the Food and Drug Administration (FDA) approved capivasertib, in combination with fulvestrant, for adult patients battling hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. This approval marks a significant step forward for those with one or more PIK3CA/AKT1/PTEN alterations.
Breakthrough Combination: Capivasertib with Fulvestrant
In a groundbreaking move, capivasertib (Truqap, AstraZeneca Pharmaceuticals) was given the green light by the FDA for use alongside fulvestrant. This approval is specifically for patients who have experienced progression on at least one endocrine-based regimen in the metastatic setting or recurrence within 12 months of completing adjuvant therapy.
Companion Diagnostic Device: FoundationOne®CDx Assay
To ensure precise treatment, the FDA also approved the FoundationOne®CDx assay as a companion diagnostic device. This tool helps identify patients with breast cancer suitable for capivasertib with fulvestrant therapy.
Clinical Trial Insights:
The approval was based on the results of the CAPItello-291 trial, a comprehensive study involving 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer. Notably, 289 patients had tumors with PIK3CA/AKT1/PTEN alterations.
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Key Findings:
The trial revealed a statistically significant difference in progression-free survival (PFS) in both the overall population and in patients with PIK3CA/AKT1/PTEN-altered tumors. In the latter group, the median PFS was 7.3 months for the capivasertib-fulvestrant group compared to 3.1 months for the placebo-fulvestrant group.
Safety and Tolerability:
Common adverse reactions included diarrhea, cutaneous adverse reactions, increased random glucose, and others. It’s crucial for patients and healthcare providers to be aware of these potential side effects and monitor for any signs of concern.
Dosage and Administration:
The recommended capivasertib dose is 400 mg orally twice daily, with or without food, for four days followed by three off days until disease progression or unacceptable toxicity.
Global Collaboration: Project Orbis
This FDA approval falls under Project Orbis, an initiative fostering collaboration among international partners for the concurrent submission and review of oncology drugs. Collaborating agencies include the Australian Therapeutic Goods Administration, Health Canada, Israel’s Ministry of Health, Singapore’s Health Sciences Authority, Switzerland’s Swissmedic, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency.
Swift Approval and Priority Review:
The FDA approved this application two weeks ahead of the goal date, underscoring its priority status. Expedited programs like these aim to accelerate the availability of promising treatments for serious conditions.
Reporting Adverse Events:
Healthcare professionals are urged to report any serious adverse events suspected to be associated with this treatment to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
The FDA’s approval of capivasertib with fulvestrant heralds a new era in breast cancer treatment. Patients, families, and healthcare providers can find solace in the collaborative efforts that led to this breakthrough. As we navigate this journey together, the promise of progress shines bright on the horizon
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About the author
Dr. Sajeve Thomas is a distinguished medical professional and a compassionate guide in the field of oncology. With over a decade of dedicated experience as a board-certified medical oncologist/internal medicine specialist, Dr. Thomas has become a trusted expert in the treatment of melanoma, sarcoma, and gastrointestinal conditions. Currently practicing at the renowned Orlando Health Cancer Institute, he brings a wealth of expertise to the complex and challenging world of oncology.