AstraZeneca Gets SEC Nod for New Trastuzumab Deruxtecan Indication in HER2-Positive Solid Tumors
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended approval for an additional indication of Trastuzumab Deruxtecan 100 mg powder for concentrate for solution for infusion, developed by AstraZeneca Pharma India Limited.
The decision comes after AstraZeneca presented additional data seeking a waiver of local clinical trials for the new indication. The SEC noted that this proposed use has already been approved in the United States, Canada, and Australia, strengthening the case for its adoption in India.
Following detailed deliberation, the committee recommended approval of the indication “for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment or who have no satisfactory alternative treatment options.”
The approval, however, is subject to AstraZeneca conducting a Phase IV study in India to collect local safety and efficacy data.
The SEC directed AstraZeneca to submit the India-specific Phase IV study protocol within three months of receiving marketing permission for this new indication. This requirement ensures that real-world evidence on Indian patients is generated, complementing global data.
This recommendation marks a significant milestone for AstraZeneca’s oncology portfolio, expanding the accessibility of targeted HER2-directed therapies for patients in India.
Trastuzumab Deruxtecan, an antibody–drug conjugate, has been recognized globally for its efficacy in advanced HER2-positive solid tumors, offering hope to patients with limited treatment options.
