Trastuzumab Deruxtecan (DS-8201a) Designated as Breakthrough Therapy in China for HER2-Mutant NSCLC

On January 3, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced thatAstraZeneca and Daiichi Sankyo jointly submittedDS-8201a (Trastuzumab Deruxtecan, Enhertu) is proposed to be included in the breakthrough therapy category, with the proposed indication as:There is activation of HER2 (ERBB2) mutated and previously received at least one systemic treatment for unresectable or metastatic non-small cell lung cancer in adult patients。Trastuzumab DeruxtecanIt is an antibody-drug conjugate (ADC) targeting HER2 jointly developed by AstraZeneca and Daiichi Sankyo. This is also the third time that the product has been proposed by the CDE to be included in the breakthrough therapy category.

Screenshot source: CDE official website

Trastuzumab Deruxtecan byHumanized monoclonal antibody targeting HER2Through a cleavable tetrapeptide linker withTopoisomerase 1 Inhibitor(DXd, a camptothecin derivative)Payload connection composition. In China, this product has previously been approved for the treatment ofHER2-positive and HER2-low adult breast cancer patients. In addition, this product has been included in the CDE's breakthrough therapy category twice before, for the indications respectively.HER2-Positive Breast Cancer、HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma。

This time,Trastuzumab deruxtecan proposed for priority review targets the indication of:HER2 activation exists (ERBB2) mutation and have previously received at least one systemic treatment for unresectable or metastaticNon-Small Cell Lung Cancer（NSCLC）Adult patients. For the NSCLC indication,Trastuzumab deruxtecan received accelerated approval from the U.S. FDA in August 2022. According to the press release previously published by the FDA, this accelerated approval was based on the positive results of the randomized, double-blind dose optimization clinical trial DESTINY-Lung02.In the primary efficacy analysis cohort comprising 52 patients,Trastuzumab DeruxtecanAchieved a confirmed objective response rate of 58% (95% CI: 43, 71), with a median duration of response of 8.7 months.。

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. Retrieved Jan 3, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer. Retrieved August 11, 2022, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-her2-mutant-non-small-cell-lung?utm_medium=email&utm_source=govdelivery

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