AstraZeneca India Pharma Ltd. (AZPIL) has secured approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Trastuzumab deruxtecan concentrate for infusion (100 mg) for an expanded use. This therapy can now be used as a monotherapy for adult patients with unresectable or metastatic HER2-low (IHC 1+ and IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have undergone at least one line of endocrine therapy in a metastatic setting.

Breast cancer remains the most frequently diagnosed cancer globally, with more than 2 million cases reported in 2020. In India, cases have risen by 40% over the past 25 years. This new approval brings hope for patients battling advanced HER2-targeted breast cancer.

Dr. Sandeep Arora, Director of Medical Affairs at AZPIL, emphasized that the approval was backed by data from the DESTINY-Breast06 trial, marking a pivotal advancement in breast cancer care. Testing for IHC staining is now essential to identify suitable patients for this treatment after endocrine therapy resistance.

Dr. Sanjeev Panchal, Country President of AZPIL, noted AstraZeneca’s commitment to innovation in oncology, stating the company aims to transform cancer care through cutting-edge science. First introduced in India in 2024, Trastuzumab deruxtecan has already gained approval for breast and gastric cancers and holds promise to significantly enhance survival outcomes.