Wednesday, August 14, 2013

National Drug Advisory Commitee for Oncology and Hematology drugs recommends approval for Roche's Pertuzumab in India for HER2+ve Breast cancer, subject to conduct of Phase IV clincial trial

The committee recommended for the waiver from local clinical trial. However, as the data on
the clinical study presented by the firm did not give any significant results on Indian population,
the firm shall first submit structured Phase IV study protocol to be conducted on Indian population for the generation of toxicity/ safety data. The protocol shall be submitted by the firm to be reviewed by NDAC members and discussed in the subsequent meeting of Oncology & Hematology


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