Lilly Korea has received sales approval from the Ministry of Food and Drug Safety for Verzenio, a metastatic breast cancer treatment, on Wednesday.
|Lilly’s metastatic breast cancer treatment Verzenio|
Verzenio is a primary endocrine therapy for postmenopausal women with HR+/ HER2-progressive or metastatic breast cancer. The drug is a next-generation target treatment for selective inhibition, cyclin-dependent kinase (CDK) 4/6, a cell-mediated protein, which inhibits cancer cell proliferation.
The ministry has approved the drug in combination with an aromatase inhibitor or as a combination therapy with fulvestrant in treating HR+/HER2-progressive or metastatic breast cancer with advanced disease after endocrine therapy.
The drug is the only CDK 4/6 inhibitor available in Korea that patients can take daily without a break period. Patients can take the medication orally twice a day, regardless of eating meals. The ministry’s approval comes after the company proved the efficacy and safety of the drug MONARCH 3, a phase 3, double-blind, placebo-controlled study.
The research participated in by 493 patients from 22 countries, including Korea, evaluated the safety and efficacy of Verzenio in combination with an aromatase inhibitor (anastrozole or letrozole), as initial endocrine-based therapy for postmenopausal women with HR+ and HER2- breast cancer who have had no prior systemic treatment for advanced disease.
As a result, the median progression-free survival (PFS) was 28.18 months, which was twice as long as the 14.76 months of the aromatase inhibitor alone group. Also, the objective response rate (ORR) was significantly higher in Verzenio treated group (48.2 percent) than in the group with an only aromatase inhibitor (34.5 percent).
The MONARCH 2 study, which compared efficacy and safety of the treatment on HR+/HER-progressive breast cancer patients who received endocrine therapy, found that the median PFS time of patients treated with the combination of Verzenio and fulvestrant was 16.4 months while and the ORR was 35.2 percent, which was significantly higher than 16.1 percent of the fulvestrant-alone group.
“The results of the sub-analysis of the two studies showed that the improvement was more pronounced in patients with poor prognostic factors such as advanced liver metastasis, high tumor grade, and treatment-free interval in advanced breast cancer,” said Professor Im Suk-ha of the department of hematology at Seoul National University Hospital. “This is significant in that it is an effective treatment option for metastatic breast cancer patients with poor prognosis.”
Lilly Korea President Paul Henry Huibers also said, “Verzenio is meaningful in that it is a new therapeutic alternative to HR+/HER2-metastatic breast cancer patients for which medical needs have not been met.”
It is particularly encouraging that positive results have been shown in patients with poor prognosis, Huibers added.