By Robin Foster HealthDay Reporter<\/b><\/p>\n
<\/b><\/p>\n
WEDNESDAY, Sept. 18, 2024 (HealthDay News) — Women with early-stage breast cancer may now take Kisqali, a medication already approved for advanced disease, following the U.S. Food and Drug Administration’s expanded approval of the treatment, drug maker Novartis announced Tuesday.<\/p>\n
\u00e2\u0080\u009cThe FDA approval of Kisqali<\/a> for this early breast cancer population, including those with NO [hasn’t spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,\u00e2\u0080\u009d said Dr. Dennis Slamon<\/a>, director of clinical\/translational research at UCLA’s Jonsson Comprehensive Cancer Center and lead investigator on the company’s trial of the drug.<\/p>\n \u00e2\u0080\u009cToday\u00e2\u0080\u0099s approval allows us to offer treatment with a CDK4\/6 inhibitor [Kisqali] to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning,\u00e2\u0080\u009d he added in a company news release<\/a>.<\/p>\n What prompted the expanded approval?<\/p>\n In a\u00a0phase 3 clinical trial<\/a> involving women with earlier stage cancers, Kisqali reduced the risk of a breast cancer coming back by 25% after three years when given along with standard treatments, which can include chemotherapy, surgery and radiation followed by hormone therapy.<\/p>\n After four years, Kisqali reduced the risk by 28.5%, according to an\u00a0updated analysis<\/a>\u00a0presented Monday at the European Society for Medical Oncology annual meeting in Barcelona.<\/p>\n \u00e2\u0080\u009cWe want to do everything that we can to incrementally decrease the chances of this cancer coming back,\u00e2\u0080\u009d Dr. Vandana Abramson<\/a>, co-leader\u00a0<\/strong>of the Breast Cancer Research Program at the Vanderbilt-Ingram Cancer Center in Nashville, Tenn., told NBC News.<\/em> \u00e2\u0080\u009cSo if a patient was already at a potentially 10% risk of the cancer coming back, this would decrease it further, down to 7%.\u00e2\u0080\u009d<\/p>\n While Verzenio<\/a>, a drug in the same class, has been approved<\/a> to lower the risk of early\u00a0breast cancer<\/a> returning, it’s only for people with a very high risk of recurrence. Kisqali will be available to a much broader group of patients, whose disease may not be as aggressive at the time of diagnosis, Novartis said.<\/p>\n The expanded approval is for patients\u00a0<\/strong>with HR-positive, HER2-negative breast cancer,\u00a0the most common form<\/a> of the disease. It’s for stage 2 and 3 cases, meaning the cancer hasn\u00e2\u0080\u0099t spread beyond the breast or nearby lymph nodes.<\/p>\n While the drug\u00e2\u0080\u0099s effects were studied for three years, research has shown that breast cancer can recur\u00a0decades after diagnosis.<\/p>\n \u00e2\u0080\u009cIt would be nice to still see additional longer follow-up data to see if we are impacting just rates of early recurrences, or will we also have an impact on\u00a0late recurrences?\u00e2\u0080\u009d Dr. Komal Jhaveri<\/a>, a breast medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told NBC News<\/em>.<\/p>\n Still, the drug will not come cheap.<\/p>\n \u00e2\u0080\u009cThe cost, out-of-pocket, if you\u00e2\u0080\u0099re taking it for the entire three years, would be close to $300,000-$400,000,\u00e2\u0080\u009d Abramson noted.<\/p>\n With the expanded approval, it\u00e2\u0080\u0099s more likely that insurance plans will offer coverage for the treatment, but that can still tax the health care system as a whole.<\/p>\n \u00e2\u0080\u009cSome of the criticisms of the study have been: well, it was only a 3% benefit,\u00e2\u0080\u009d Dr. Eleonora Teplinsky<\/a>, head of breast and gynecologic medical oncology at Valley Health System in New Jersey, told NBC News.<\/em> \u00e2\u0080\u009cThree percent more patients benefit. What does that mean? But I think that\u00e2\u0080\u0099s then up to the patient to decide what they want to do. It\u00e2\u0080\u0099s important for them to have the option.\u00e2\u0080\u009d<\/p>\n More information<\/strong><\/p>\n The American Cancer Society has more on breast cancer<\/a>.<\/p>\n