Breast cancer drug Nerlynx can be prescribed

as non reimbursed drug

It passed the Big 5 Pharmaceutical Affairs Committee such as SMC, Seoul National University Hospital, Severance, and AMC

Announcement of re-challenge for benefit in the second half of the year

Breast cancer drug Nerlynx can be prescribed in general hospitals.

 

According to related industries, the oral tyrosine kinase inhibitor Nerlynx, which inhibits Bixink Therapy's HER2 protein, passed the Drug Committee (DC) of the Big 5 Advanced General Hospital, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital.

 

However, as it is still a non-reimbursed drug, it is expected to take some time until the prescription is reimbursed.

 

This drug was submitted to the Health Insurance Review and Assessment Service in February, but it was judged that the benefit standard was not set.

 

Bixink Therapetics plans to submit it again in the second half of this year.

 

HER2-positive early breast cancer has a 1.89 times higher tendency of brain metastasis than HER2-negative breast cancer.

 

The high incidence of brain metastasis is interpreted to mean that it directly affects the survival rate.

 

When comparing the 5-year survival rate of metastatic breast cancer in Korea, the 5-year survival rate of patients with cerebral metastasis is only 10.7%, which is a significant difference compared to the 34% of patients with metastatic breast cancer.

 

Compared to the past, a number of HER2-positive early breast cancer target treatments have been developed.

 

However, in the case of current standard therapy treatments, drugs that prevent brain metastasis or prove treatment effects are still insufficient.

 

In a five-year long-term follow-up study, Nerlynx reduced the risk of recurrence or death in HER2-positive early breast cancer women by 42% and reduced the risk of developing or dying of brain metastasis by more than 59%.

 

Nerlynx was originally a drug developed by Puma Biotechnology in the U.S., and was first approved by the U.S.

 

FDA as an extended adjuvant therapy for early HER2 positive breast cancer patients in July 2017.

 

In February 2020, the indication for the treatment of metastatic HER2 positive breast cancer was expanded.

 

Bixink introduced Nerlynx in Korea in October last year, and the current indication is "extension adjuvant therapy for early breast cancer patients who are HER2 positive and hormone receptor positive within one year of the completion of Herceptin-based treatment after surgery."