Kisqali gets a nod from MFDS joining Ibrance and Verzenio

MFDS approves after MONALEESA-7 demonstrates notable efficacy

Anticipation for CDK4/6 combination therapy heightens

Following the footsteps of Ibrance and Verzenio, a third CDK4/6 inhibitor announced its launch in Korean market.

 

On Oct.

 

30, Novartis officially released news that Kisqali (ribociclib) has been approved by Ministry of Food and Drug Safety (MFDS) as a treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.

 

Ongoing competition between Ibrance and Verzenio, currently in insurance reimbursement review process as a combination therapy with Faslodex (fulvestrant), is to intensified even more.

 

Kisqali was approved by the regulator as it demonstrated a meaningful improvement of prolonging progression free survival (PFS) from its clinical trial.

 

Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as first-line treatment for pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer and proved the drug’s effect on significantly extending patient’s overall survival (OS).

 

Professor Im Seock-Ah of Hemato Oncology Department at Seoul National University Hospital explained, “MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample.

 

This finding reflects how Asian region has a great need for a new treatment on premenopausal women with breast cancer”.

 

In the Phase 3 MONALEESA-3, Kisqali proved to extend OS and demonstrated improved treatment efficacy when used as initial endocrine-based therapy in combination with fulvestrant for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination than using the existing endocrine-based therapy alone.

 

The recommended dose of Kisqali is taking 600mg (three 200mg tablets) orally, once daily for 21 consecutive days followed by seven days off treatment.

 

The treatment could be taken with or without food but at set time of the day.

 

Meanwhile, Ibrance and Verzenio are waiting for deliberation by Drug Reimbursement Evaluation Committee (DREC) after Cancer Disease Deliberation Committee of Health Insurance Review and Assessment Service (HIRA) has passed both.

 

Reimbursement review process of the both treatments started from same point of origin, cyclin-dependent kinase (CDK) 4 and 6.

 

But their regulator review approaches are different.

 

In November of 2017, Ibrance has already been listed as a first-line therapy (combination with Letrozole) via refund type risk sharing agreement (RSA).

 

And now it is in process of expanding the reimbursed indication.

 

Verzenio, on the other hand, is applying for reimbursement listing for the first time.

 

The treatment has simultaneously applied for reimbursement not only as a second-line therapy, but also as a first-line therapy in combination with aromatase inhibitor.

 

But under its current circumstances, Verzenio’s only option is RSA.

 

Unfortunately, a follow-on drug is not yet eligible for RSA, so Lilly would likely to push on with the second-line therapy indication without any other drug available.

 

Kisqali would also likely to take the same track.