AstraZeneca Pharma has successfully secured approval from India’s national drug regulator to introduce a vital new cancer treatment to the market.
The company confirmed that it received the green light from the Central Drugs Standard Control Organisation (CDSCO) to import, market, and distribute Trastuzumab Deruxtecan for an expanded range of indications across India.
Thanks to this approval, Trastuzumab Deruxtecan can now be used to treat adult patients suffering from unresectable or metastatic HER2-positive solid tumors. These are patients who have previously undergone systemic therapy and have no other suitable treatment options available.
This landmark decision positions Trastuzumab Deruxtecan as the first and only antibody-drug conjugate in India with a tumor-agnostic indication, marking a monumental leap forward in the field of precision oncology.
Praveen Rao Akkinepally, Country President and Managing Director of AstraZeneca Pharma India, highlighted the significance of this achievement. “This milestone underscores our unwavering dedication to prioritizing patients, upholding scientific excellence, and ensuring fair access to innovative therapies. By making Trastuzumab Deruxtecan available to Indian patients with HER2-positive solid tumors, we are taking a crucial step towards addressing critical unmet medical needs and revolutionizing cancer care,” he stated.
It’s important to note that Trastuzumab Deruxtecan was already approved in India for treating various forms of metastatic breast cancer (including HER2-positive, HER2-low, and HER2-ultralow subtypes) and for locally advanced or metastatic gastric cancer.
The new tumor-agnostic approval significantly expands the drug’s therapeutic reach, offering hope and potential benefits to a broader spectrum of patients battling advanced HER2-positive cancers.