FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Roche Wins Approval for Post-Op Breast Cancer Treatment

May 16, 2019

The FDA approved Roche’s Kadcyla to help treat breast cancer patients after their surgeries.

Kadcyla (trastuzumab emtansine) is indicated for patients with HER2-positive early breast cancer who have residual disease after pre-surgical treatments.

The approval comes just 12 weeks after Roche submitted for it under the FDA’s Real-Time Oncology Review and Assessment Aid pilot, designed to help speed drugs through to the market.

The approval comes after Roche presented results from a Phase III trial, which reduced the risk of breast cancer coming back by half in patients in the Kadcyla group.

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