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 sy

See Full Page