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CDK4/6 inhibitor+fulvestrant combo nears getting benefit
  • By Kim Yun-mi
  • Published 2019.10.02 16:03
  • Updated 2019.10.02 16:03
  • comments 0

The combination therapy of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor and fulvestrant for advanced or metastatic breast cancer has taken the first step to receive insurance benefits.

The Health Insurance Review and Assessment Service (HIRA)’s Cancer Drug Review Committee decided in September to grant reimbursement for Pfizer’s Ibrance (ingredient: palbociclib) plus fulvestrant and Lilly’s Verzenio (abemaciclib) plus fulvestrant, sources said on Monday.

Earlier, AstraZeneca’s Faslodex (fulvestrant) won reimbursement in April, 11 years after the market release. This prompted Pfizer to seek reimbursement immediately for the combo of Ibrance and fulvestrant. Lilly released rival drug Verzenio and applied for insurance benefit in July. Then, the HIRA’s cancer drug review panel discussed it in September.

The U.S. National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) recommend Ibrance plus fulvestrant as the category 1 treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) metastatic breast cancer. In Korea, however, physicians found it difficult to use the non-reimbursable combo therapy.

Recently, drug companies announced the results of trials on the combo, saying CDK4/6 inhibitors such as Verzenio and Kisqali (ribociclib) plus fulvestrant improved overall survival in women with HR+/HER2- advanced or metastatic breast cancer, before or after menopause, compared to fulvestrant alone.

At the ESMO Congress 2019 in Barcelona, Spain, on Sunday, researchers released the overall survival data from the phase-3 MONARCH-2 on Verzenio and the MONALEESA-3 on Kisqali, respectively.

The MONARCH-2 study compared Verzenio plus fulvestrant with fulvestrant alone in patients with HR+/HER2- advanced or metastatic breast cancer previously treated with endocrine therapy. The women were either pre- or post-menopausal.

During the 47.7-month follow-up, the median overall survival of the group treated with Verzenio plus fulvestrant was 46.7 months, versus 37.3 months in the fulvestrant alone group. The combo therapy reduced the risk of death by 24.3 percent.

The MONALEESA-3 study compared Kisqali plus fulvestrant with fulvestrant alone as the first-line treatment in postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. The study included newly diagnosed patients, those without endocrine therapy experience, patients who relapsed within 12 months after adjuvant therapy, and those who underwent endocrine treatment for the progressive disease.

The analysis of the overall survival, which was the secondary endpoint of the study, showed that Kisqali plus fulvestrant group did not reach the median overall survival with a 27.6 percent reduction in risk of death, while the fulvestrant group had 40 months in overall survival.

The latest data was also published in JAMA Oncology.

Even though Novartis has yet to obtain local approval for Kisqali, the Central Pharmaceutical Affairs Review Committee recently disclosed positive results of its review whether the dose of Kisqali was appropriate and whether there was any blood toxicity problem.


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