Perjeta Panel Review Could Pave Way For Neoadjuvant Approvals

The September advisory committee review of Roche’s sBLA for Perjeta will be the first test of the agency’s guidance on using accelerated approval for neoadjuvant breast cancer.

FDA’s upcoming advisory committee review of Roche/Genentech Inc.’s Perjeta for a new indication in neoadjuvant breast cancer will help lead the way for approvals of drugs in early treatment, a new paradigm for oncology drug development.

The Oncologic Drugs Advisory Committee will meet Sept. 12 to consider a supplemental BLA for Perjeta (pertuzumab) in patients with...

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