AstraZeneca Gets SEC Nod for New Trastuzumab Deruxtecan Indication in HER2-Positive Solid Tumors

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.