FDA
11th September 2013

Meeting Materials NOW Available! – PERJETA (pertuzumab) injection

 In this meeting, the committee will discuss supplemental biologics license application 125409/51, with the trade name PERJETA (pertuzumab) injection, application submitted by Genentech, Inc.

Meeting Materials NOW Available! – PERJETA (pertuzumab) injection

September 12, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Oncologic Drugs Advisory Committee Meeting

In this meeting, the committee will discuss supplemental biologics license application 125409/51, with the trade name PERJETA (pertuzumab) injection, application submitted by Genentech, Inc. The proposed indication (use) for this product is in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer (tumor greater than 2 cm in diameter) as part of a complete early breast cancer regimen containing either fluorouracil, epirubicin, and cyclophosphamide or carboplatin.

Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

 

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