FDA Broadens Use of Breast Cancer Drug Kisqali

On Wednesday, Sept. 18, 2024, Novartis announced that the U.S. Food and Drug Administration (FDA) has extended the approval of Kisqali, a medication previously authorized for advanced breast cancer, to include women with early-stage breast cancer. This significant expansion now allows a broader group of women to access the treatment.

Dr. Dennis Slamon, a key figure in the clinical research at UCLA's Jonsson Comprehensive Cancer Center, highlighted the importance of this development. He noted that the FDA's decision to approve Kisqali for early-stage breast cancer, even for those whose cancer has not spread to nearby lymph nodes, marks a crucial advancement in breast cancer care. Dr. Slamon emphasized that this approval paves the way for more patients to use Kisqali in combination with endocrine therapy to reduce the risk of cancer recurrence.

The decision to broaden the use of Kisqali was based on data from a phase 3 clinical trial. The study revealed that, when combined with standard treatments like chemotherapy, surgery, and radiation, Kisqali reduced the risk of breast cancer recurrence by 25% after three years. An updated analysis presented at the European Society for Medical Oncology annual meeting in Barcelona showed that after four years, Kisqali reduced the recurrence risk by 28.5%.

Dr. Vandana Abramson of Vanderbilt-Ingram Cancer Center pointed out that even for patients with a 10% baseline risk of cancer recurrence, Kisqali could potentially reduce this risk to 7%. While Verzenio, another drug in the same class, is approved for reducing the risk of early breast cancer recurrence in patients with a very high risk, Kisqali's approval applies to a broader patient group, including those with less aggressive disease at diagnosis.

Kisqali's expanded approval specifically targets patients with HR-positive, HER2-negative breast cancer. This category, the most common form of breast cancer, includes stage 2 and 3 cases where the disease has not spread beyond the breast or nearby lymph nodes. Although Kisqali's effects were studied over three years, the concern remains that breast cancer can recur decades after the initial diagnosis. Dr. Komal Jhaveri from Memorial Sloan Kettering Cancer Center expressed a desire for additional long-term data to understand whether Kisqali impacts both early and late recurrences.

One major consideration is the cost of the drug. Dr. Abramson estimated that the out-of-pocket expense for a three-year course of Kisqali could range from $300,000 to $400,000. Despite the high cost, the expanded approval increases the likelihood that insurance plans will cover the treatment, although this may place additional strain on the healthcare system.

Dr. Eleonora Teplinsky of Valley Health System in New Jersey addressed some criticisms of the clinical study, noting that the 3% benefit might seem minimal. However, she argued that the decision to use Kisqali should ultimately be up to the patient, emphasizing the importance of providing them with the option.

In summary, the FDA's expanded approval of Kisqali offers new hope for women with early-stage breast cancer, providing them with an additional tool to reduce the risk of cancer recurrence. While the financial implications are significant, the potential benefits for a broader patient population make this a pivotal development in breast cancer treatment.