Kisqali, a key targeted therapy for breast cancer from Novartis, until now has been indicated only for patients with metastatic disease. But on Tuesday, the Food and Drug Administration approved Kisqali in combination with hormone therapy for patients with certain early-stage breast cancers, significantly expanding the number of patients who will have access to this type of drug.
“It includes the entire stage 3 and 70% of stage 2. That’s two times the size of what other CDK4/6 inhibitors are approved for,” said Victor Bulto, president of the Novartis United States unit.
Kisqali, also called ribociclib, specifically targets proteins called CDK4 and 6, which can enable cancer cells to grow and divide uncontrollably when overactive. For several years, CDK4/6 inhibitors have been a key part of treatment for advanced hormone receptor positive, HER2 negative breast cancer, the most common form of breast cancer. Last year, the FDA approved Eli Lilly’s CDK4/6 inhibitor, abemaciclib or Verzenio, for use in stage 2 and 3 HR positive, HER2 negative breast cancer, but not for breast cancers that had not yet spread to nearby lymph nodes.
This new approval for Kisqali takes that extra step, now for the first time offering CDK4/6 inhibitors to patients who don’t have positive lymph nodes. “It is not known which of these therapies is best,” said Harold Burstein, a breast cancer oncologist and researcher at Dana-Farber Cancer Institute who did not work on the drugs. The approval makes it possible for patients who might not have been considered candidates for Verzenio to receive a CDK4/6 inhibitor, Burstein said, adding it extended that opportunity to a “somewhat larger group of patients.”
These patients will be able to receive Kisqali with endocrine therapy for three years after surgery to help reduce the risk of recurrence. According to data from Novartis’ Phase 3 NATALEE trial presented this week at the European Society of Medical Oncology meeting in Barcelona, Kisqali can reduce the risk of recurrence by 28.5% compared to endocrine therapy alone. That was an analysis done in patients a year after they had completed treatment.
“We’re treating them to hopefully avoid recurrence in their lifetime. Physicians wanted to see if the effect remained and deepened even when patients stop taking treatment,” Novartis’ Bulto said. “It means they are not in active treatment for a year, and we still see a benefit and a deepening benefit.”
Kisqali does come with some side effects. The most common were low white blood cell counts and joint pain, and the drug is meant to be taken for three years after surgery. Verzenio, on the other hand, is taken for two years, but can cause diarrhea. That underscores the importance of early detection, said Dana-Farber’s Burstein, since breast cancers at even earlier stages can often be treated effectively without the need for CDK4/6 inhibitors or even chemotherapy.
