Entry of HER2-low breast cancer Tx imminent in Korea

MFDS complete safety and efficacy review of Enhertu… commercialization imminent

Daiichi Sankyo Korea and AstraZeneca Korea’s human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) “Enhertu Inj (trastuzumab deruxtecan)” is expected to be approved in Korea soon.

 

This imminent entry of the first treatment for HER2-low breast cancer in Korea attracting much attention.

 

According to industry sources on the 24th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Enhertu.

 

With the completion of the safety and efficacy review, the industry analysis is that the drug will be soon approved if no other variables arise.

 

Enhertu, which has indications for breast and gastric cancer, was first approved for the treatment of recurrent metastatic HER-positive breast cancer in the US in 2019.

 

Since then, Enhertu was additionally approved in the US for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received prior standard treatment with “Herceptin(trastuzumab)” last year.

 

In Korea, the drug has been under regulatory review after the MFDS granted Enhertu an Expedited Review Designation in June last year.

 

If approved, patients who have difficulty using Herceptin or Perjeta due to low HER2 expression are expected to benefit from the marketing authorization of Enhertu in Korea.

 

Although HER2 protein is generally expressed in breast cancer, it is also found in some other types of cancer.

 

One out of five gastric cancer patients in the US is diagnosed with advanced HER2-positive gastric cancer.

 

In October last year, the European Society for Medical Oncology Clinical Practice Guidelines were updated to recommend Enhertu for use as the preferred second-line therapy for patients with HER2 positive metastatic breast cancer following progression with a taxane and trastuzumab, based on the results of DESTINY-Breast03 trial.

 

In July this year, the European Commission approved Enhertu as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.