Novartis’ breast cancer treatment wins regulator’s nod

Lee Han-soo  Published 2019.10.31  17:35  Updated 2019.10.31 17:35


Novartis Korea said that the Ministry of Food and Drug Safety has approved Kisqali, a kinase inhibitor, for the treatment of women with advanced or metastatic breast cancer.

Novartis' breast cancer treatment Kisqali

According to the company, less than 5 percent of Korean breast cancer patients are initially diagnosed with metastatic breast cancer. However, over 40 percent of Korean women who were initially diagnosed and treated early are later diagnosed with metastatic breast cancer.

Metastatic breast cancer is a stage 4 breast cancer that has spread beyond the breast and nearby lymph nodes to other organs in the body (most often the bones, lungs, liver or brain), which, in turn, makes it difficult to treat. The goal of treatment is to prolong survival while minimizing the side effects of treatment with continued relapse.

Notably, the proportion of premenopausal patients in Korea is more than twice higher than in the West. Premenopausal breast cancer is more aggressive and has a poorer prognosis than postmenopausal breast cancer and has a higher risk of recurrence and metastasis.

The ministry approved the drug based on clinical findings demonstrating clinical efficacy, such as the significant prolonged survival rate of Kisqali.

The phase 3 Monaleesa-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with advanced or metastatic breast cancer.

The results showed that Kisqali plus endocrine therapy resulted in a statistically significant longer overall survival compared with endocrine therapy alone.

“Monaleesa-7 is a leading clinical study proposed and conducted by an Asian researcher,” said Professor Im Seok-ah at Seoul National University Hospital. “As Asian patients accounted for 30 percent of the total enrolled patients, the study reflected the particularly high need for new treatments for premenopausal breast cancer in Asia.”

In the last two decades, clinical studies focused on premenopausal advanced and metastatic breast cancer have been underrepresented, with little interest in new treatment options, Im added.

Shin Su-hee, Novartis Korea’s oncology unit general manager, also said, “With the approval, Kisqali has become the only cyclin-dependent kinase 4/6 (CDK4/6) inhibitor that can be used as a first-line treatment for both menopausal and premenopausal advanced and metastatic breast cancer patients,”

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