AstraZeneca India Gains Approval for Solid Tumor Therapy

For a second indication, UK pharmaceutical giant AstraZeneca India has obtained expanded approval for its cancer treatment Trastuzumab Deruxtecan.

The most recent approval was obtained for the solid tumor indication, and the innovative therapy was approved in 2024 for gastric cancer and HER2-Low-metastasized breast cancer.

The authorization has been given on the findings of a multi-center global clinical trial investigating safety and efficacy where the drug has showed a median progression-free survival rate of 11.9 months in patients with a solid tumor. The other two indications have reported a progression-free survival of 6.7 months for lung cancer and 5.8 months in colorectal cancer patients.

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" By bringing Trastuzumab Deruxtecan to patients in India with HER2-positive solid tumors, we take a significant step forward in addressing unmet medical needs and transforming cancer care," said Praveen Rao Akkinepally, Country President and MD, Astra Zeneca Pharma India Limited

Trastuzumab Deruxtecan is marketed as Enhertu and according to the company’s fiscal year end results the brand surpassed 1.9 billion (over Rs 16,000 cr) for the remainder of 2024 The engineered therapy is intended to bind to HER2 (Herceptin) proteins to inhibit pairing with other proteins initiating the receptor to send cancer growth signals in turn slowing, stopping, and reversing the growth.