Shots:

• The approval is based on a P-II (HUON-003-01) study to evaluate the efficacy and safety of Herceptin + docetaxel in 16 patients with HER2-positive advanced or recurrent salivary gland cancer (HER2 overexpression assessed by VENTANA ultraView Pathway HER2 (4B5) and VENTANA DISH HER2 approved on Nov 11, 2021 as CD)
• The 1EPs of the trial demonstrated that 60% of patients showed a response in the efficacy analysis population
• Herceptin is an anti-HER2 humanized mAb. In 2011, the therapy received approval for the treatment of patients with advanced or recurrent gastric cancer overexpressing HER2 not amenable to curative resection & also received ODD from the MHLW for the same indication on Mar 11, 2021

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Ref: Chugai | Image: Chugai