The FDA has approved.
Women diagnosed with early-stage breast cancer can now use Kisqali, a drug previously approved for advanced cases, following its recent expanded approval by the U.S. Food and Drug Administration (FDA), as announced by Novartis.
Dr. Dennis Slamon, director of clinical and translational research at UCLA’s Jonsson Comprehensive Cancer Center, highlighted the significance of this approval, noting that it enables healthcare providers to use Kisqali—a CDK4/6 inhibitor—in conjunction with endocrine therapy. This combination aims to reduce the risk of cancer recurrence for a broader group of patients, including those with no spread to nearby lymph nodes.
The FDA’s decision was based on results from a phase 3 clinical trial, which demonstrated that Kisqali, when combined with standard treatments like chemotherapy, surgery, and radiation, lowered the risk of breast cancer recurrence by 25% over three years. An updated analysis presented at the European Society for Medical Oncology annual meeting showed that this reduction increased to 28.5% after four years.
Dr. Vandana Abramson from the Vanderbilt-Ingram Cancer Center noted that for patients with an initial 10% risk of recurrence, Kisqali could reduce that risk to 7%. While another drug in the same category, Verzenio, is available for patients with a very high risk of recurrence, Kisqali is now accessible to a wider range of individuals with less aggressive disease at the time of diagnosis.
The expanded approval targets patients with HR-positive, HER2-negative breast cancer, the most prevalent type, specifically for stage 2 and 3 cases. Although the clinical trials examined the drug’s effects over three years, experts like Dr. Komal Jhaveri from Memorial Sloan Kettering Cancer Center have expressed the need for longer-term data to determine whether Kisqali also affects late recurrences.
However, the cost of treatment is significant, with estimates ranging from $300,000 to $400,000 for a full three-year course. While the expanded approval may lead to better insurance coverage for Kisqali, it still poses challenges for the healthcare system. Dr. Eleonora Teplinsky emphasized that, despite concerns about the modest benefits observed in trials, the option to use this treatment remains crucial for patients to consider in their care.
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