FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Roche Wins Approval for Perjeta in Breast Cancer Subgroup

Feb. 26, 2019
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The UK’s National Institute for Health and Care Excellence (NICE) recommended Roche’s Perjeta (pertuzumab) for early HER2-positive breast cancer where the disease has spread to patients’ lymph nodes.

NICE previously recommended Perjeta in combination with trastuzumab and chemotherapy for breast cancer patients who are awaiting surgery and for recurring or metastatic breast cancer. But the reviewers were uncertain about recommending Perjeta alone for cancers that have spread into the lymph nodes — noting evidence that the drug combination increased the proportion of patients whose cancer didn’t spread but that it is unclear whether Perjeta actually increases the amount of time cancer patients live.

NICE issued the draft recommendation for use of the drug by the National Health Service after Roche offered a price discount and provided a revised economic analysis focused on the specific subgroup of lymph node patients.

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