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The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

A statistically significant improvement in the total pathologic complete response rate, the primary end point of the study, was observed with neoadjuvant treatment of pertuzumab, trastuzumab and docetaxel compared with placebo, trastuzumab, and docetaxel in Asian patients with&nbsp;<a><em>ERBB2</em></a>&nbsp;-positive early or locally advanced breast cancer, according to the phase III PEONY trial.