United States: Drug maker Novartis who recently said in press release on Tuesday that women with early-stage breast cancer can now take Kisquali, which is a medication that is approved for late stage breast cancer following the US Food and Drug Administration’s latest approver.
As reported by the HealthDay, “The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn’t spread to nearby lymph nodes] disease, is a turning point in enhancing the way the community treats this disease,” noted Dr. Dennis Slamon, the director of clinical/translational research at UCLA Jonsson Comprehensive Cancer Center and the trial physician on the company’s trial of the drug.
“Today’s approval means we can provide treatment with a CDK4/6 inhibitor [Kisquali] to a significantly larger population as a robust tool in combination with endocrine therapy to better prevent cancer recurrence,” he commented in the company’s press release.
This brings into the picture the following questions: What led to the expanded approval?
In a phase 3 study with 1718 postmenopausal women with earlier stages of disease Kisqali lowered the chance of breast cancer recurrence by almost 25 percent in the following three years when combined with chemotherapy surgery and radiation followed by hormone therapy.
Kisqali cut the risk by 28% after four years of use according to the study. 5 percent if a new analysis that was presented on Monday during the European Society for Medical Oncology annual meeting in Barcelona is to be believed.
“We want to do everything that we can to incrementally decrease the probability of this cancer recurring,” Abramson, who is also the co-leader of the Breast-Cancer Research Program at the Vanderbilt-Ingram Cancer Center located in Nashville, Tenn., said to NBC News. “Thus, if a patient is at a potentially 10 percent chance of the cancer recurring, this would be lowered to 7 percent by the usage of the drug.”
Verzenio, a drug which belongs to the same category, has been approved to reduce the chances of early breast cancer coming back, but this is only for those with high chances of the cancer coming back again. Also, Kisqali will also be available to a much broader group of the patients whose disease may not be as aggressive at the time of the diagnosis, Novartis said.
The expanded approval is for the patients with HR-positive, HER2-negative breast cancer, the most common form of the disease and its’s for the stage 2 and 3 cases and the meaning of the cancer hasn’t spread beyond the breast or nearby lymph nodes.
While the drug’s effects were studied for the three years and the research has shown that the breast cancer can recur the decades after the diagnosis.
Also it would be nice to still to see the additional longer follow-up data to see if we are impacting just the rates of the early recurrences or will we also have an impact on the late recurrences? Dr. Komal Jhaveri a breast medical oncologist at the memorial Sloan Kettering Cancer-Center which is in the New York told the NBC news.
Still, the drug will not come cheap.
It’s actually costing much like we can say the cost is out of the pocket and if you’re taking it for the entire three years and would be close to the USD 300,000 and USD 400,000 noted by Abramson.