Roche’s Master Plan: Perjeta Gains Early Breast Cancer Approval, Late-Stage Kadcyla Data
Perjeta’s approval in neoadjuvant breast cancer signals paradigm change as first approval under new pathway. Meanwhile, antibody-drug conjugate Kadcyla proves its worth in heavily pretreated, advanced breast cancer.
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KATHERINE supports filings for earlier use of Kadyla in adjuvant setting of breast cancer.
Better than expected FDA labeling for rising star Perjeta in neoadjuvant (before surgery) and adjuvant (after surgery) breast cancer could boost sales greatly beyond expectations, some analysts say.
Five neoadjuvant breast cancer regimens have been tested successfully in I-SPY Phase II program, but three have not moved on to sponsor-driven pivotal testing and the I-SPY 3 master protocol has yet to be used.