Kadcyla can be prescribed after registering benefit

Active to target early breast cancer from positive to negative HER2

Verzenio gets additional approval for Indication

According to related industries, anticancer drugs such as ADC and Antibody-drug conjugate Kadcyla and CDK4/600 inhibitor Verzenio are entering the early breast cancer area in Korea.

 

Kadcyla was already listed on the insurance benefit list in July, and the actual prescription began.

 

The drug, which was used for the second or more treatment of HER2-positive metastatic breast cancer, has expanded access to postoperative adjunct therapy in HER2-positive early breast cancer patients with invasive residual lesions after receiving prior chemotherapy, including Taxane and Trastuzumab.

 

The effectiveness of Kadcyla's early breast cancer was confirmed through an open-label study in phase 3 (KATHERINE).

 

KATHERINE is a study comparing the efficacy and safety of the Kadcyla-only and Trastuzumab-based preoperative adjuvant group in 1,486 HER2-positive early breast cancer patients who were confirmed to have invasive residual lesions in the surgical site or armpit lymph nodes even after undergoing taxane and Trastuzumab-based preoperative adjuvant therapy.

 

As a result of the study, the 3-year invasive disease-free survival (iDFS) of the Kadcyla solo administration group was 88.3%, an 11.3% improvement over the Trastuzumab solo administration group (77.0%), and a 50% reduction in the risk of disease recurrence or death.

 

Verzenio succeeded in securing HER2-negative early breast cancer indication.

 

This drug obtained additional approval from the Ministry of Food and Drug Safety on the 19th for HR+/HER2-, high-risk early breast cancer with lymph node-positive recurrence.

 

The enlargement of the indication was based on the results of the Phase III clinical study cohort 1 of Verzenio's monarchE in 5,637 adult women and men at high risk of lymph node-positive type HR+/HER2- who underwent resection.

 

As a result of the monarchE study, both IDFS (Invisible Disaster-Free Survival) and DRFS (Distant Relapse-Free Survival) at the time of follow-up 3 years showed significant improvement compared to the control group in the Verzenio administration group.

 

The Verzenio administration group showed a 30% reduction in risk of recurrence and death within 3 years compared to the control group (88.8% of the 3-year IDFS ratio with Verzenio+endocrine therapy, 83.4% of the endocrine therapy alone), and a 31% decrease in risk of remote recurrence and death.

 

The proportion of early breast cancer patients, which is between 0 and 1, accounts for more than half of the total breast cancer patients (as of 2018), emphasizing the importance of reducing recurrence rates through optimal treatment.