Star ADC Therapy DS-8201 approved for market in China!

Detrastuzumab, an injectable drug developed by AstraZeneca and Daiichi Sankyo, has been officially approved for sale in China, the National Drug Administration (NMPA) said on its website on February 24.

DS-8201 (Enhertu, trastuzumab) is an antibody conjugated drug (ADC) targeting HER2 with a cleavable linker and a topoisomerase-1 inhibitor as a linked cytotoxic drug.

In the United States, DS-8201 received an indication for breast cancer in December 2019 for the treatment of third-line HER2-positive breast cancer in patients with unresectable or metastatic HER2-positive breast cancer. Based on the latest results from DESTINY Breast03, DS-8201 has been listed as the preferred second-line treatment for HER2-positive, relapsed, unresectable or stage IV breast cancer in the V1 version of the 2022 NCCN Guidelines.

In China, the April 2022 marketing application for DS-8201 was included in the priority review for the proposed indication of monotherapy for unresectable or metastatic HER2-positive breast cancer treated with one or more previous anti-HER2 drugs. This is the first time that the drug has been approved in China, adding a new star to the domestic clinical treatment of advanced breast cancer.

In addition, DS-8201 was approved for locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma as a breakthrough therapy designation for patients with HER2-mutated metastatic non-small cell lung cancer whose disease progresses during or after platinum-based chemotherapy, and for HER2-positive colorectal cancer with good clinical trial data. He is a versatile cancer fighter.

Notably, DS-8201 significantly extended progression-free survival and overall survival compared with chemotherapy in a pivotal Phase III trial in patients with unresectable or metastatic breast cancer with low HER2 expression, and the results of this trial are expected to change the treatment landscape for breast cancer with low HER2 expression.

In recent years, the competition of ADC research and development track in China has been heated up. For the indication of breast cancer, the target of ADC research focuses on HER2 and TROP2. Now DS-8201 has been approved for market first.