FDA recommends accelerated approval of Perjeta for early-stage HER2+ treatment

PJ Hamel Health Guide
  • In news announced Sept. 10, pertuzumab (Perjeta™) has been placed into an accelerated approval process by the FDA for use by women with early-stage HER2+ breast cancer, as well as those in advanced stages of the disease. In a small study researching pertumuzab’s role in shrinking tumors prior to surgery, the drug, used in combination with chemotherapy and Herceptin, showed an 86% improvement over current treatment methods (Herceptin and chemotherapy alone). Fully 39% of women treated with the new protocol before their surgery “saw their cancer reach undetectable levels.” ("Perjeta may be," 2013) The FDA will issue its decision on final approval Oct. 31. A positive decision would mark the first time the FDA has granted approval to any cancer drug designed as a pre-surgical option.

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    This announcement comes as a significant update to the FDA's initial approval of Perjeta for stage IV HER2+ survivors 2012 (article below).


    If you’re one of the 20% of breast cancer survivors with HER2+ cancer, an important improvement in treatment has just been made: the FDA has approved Perjeta (pertuzumab) which, given in combination with Herceptin and Taxotere to women whose cancer has metastasized, appears to extend progression-free survival (PFS) by about 6 months: 50% longer than current treatments offer.

    With so much media coverage of dysfunctional DC these days, it’s great to be able to report that our government has just done something wonderful for a certain subset of breast cancer survivors.

    The FDA invoked its priority review program for Perjeta, a potentially life-extending drug for HER2+ survivors, in the process jumping it over many of the high hurdles cancer drugs often face. And last week, Perjeta gained its all-important FDA approval.

    The drug’s manufacturer, Genentech, says Perjeta will be available almost immediately (by July 1) to women who need it right now: women facing stage IV breast cancer – and its median survival rate of just about 1 year.

    “Given the need for additional treatments for metastatic breast cancer, we made the decision to approve this drug today and not to delay its availability to patients pending resolution of the production issues relating to future supply,” said the FDA’s Dr. Janet Woodcock in a press release highlighting the drug’s approval. (Jefferson, 2012)

    Let’s back up a bit. The current treatment for HER2+ breast cancer is chemotherapy followed by a year of Herceptin. For metastatic (stage IV) HER2+ breast cancer, Herceptin is usually repeated, this time with the addition of Taxotere, another cancer drug.

    In January, the New England Journal of Medicine reported results of a phase 2 trial showing that Herceptin plus Taxotere plus a new drug – Perjeta (pertuzumab) – increased PFS from 12.4 months to 18.5 months: a 6-month improvement, just about 50% better than the current treatment.

    Thankfully, adding Perjeta to Herceptin/Taxotere doesn’t increase the risk of serious side effects (such as heart issues); though the study did show increased incidence of fever and diarrhea.  

  • So, what’s the down side? There has to be one, right?

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    Actually, there are two major potential roadblocks.

    First, Genentech has had difficulty producing sufficient supplies of the drug on a regular schedule. Genentech cites “production issues” – the genetically engineered cells needed to produce Perjeta are growing more slowly than expected. And the FDA has responded by noting that it will closely watch production, to ensure that patients being treated with Perjeta don’t suddenly find the supply has dried up.

    Second, Perjeta is expensive: just under $6,000 a month, for the typical patient. With Herceptin costing about $4,500/month, an 18-month, life-extending protocol can cost upwards of $187,000. Genentech says it will help eligible patients with those costs.

    Despite supply issues and cost, however, news of a successful new treatment – and the fact that it’s available immediately – can only be heartening to those looking at what can be a bleak future: stage IV breast cancer survivors.

    Are you a woman with stage IV, HER2+ breast cancer who originally received first-line treatment, but hasn’t yet been treated for the metastasis? Then Perjeta might be right for you. Discuss Perjeta with your oncologist; if s/he’s not yet familiar with it, and/or affordability will be an issue, share this information from Genentech (the drug’s manufacturer):

    “Genentech is committed to helping people who need Perjeta. Genentech Access Solutions is available to provide doctors and patients coverage and reimbursement support, patient assistance and information resources. Doctors can contact Genentech Access Solutions at http://www.GenentechAccessSolutions.com or 1-888-249-4918.” (Wilson, 2012)


    Baselga, J., et. al. (2012, January 12). Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMoa1113216


    Perjeta may be first early-stage breast cancer pharmaceutical option. (2013, September 10). Retrieved from http://www.cbsnews.com/8301-204_162-57602238/perjeta-may-be-first-early-stage-breast-cancer-pharmaceutical-option/


    Pollack, A. (2012, June 8). Genentech wins approval for new breast cancer drug. Retrieved from http://www.nytimes.com/2012/06/09/business/genentech-wins-approval-for-new-breast-cancer-drug.html 

    Jefferson, E. (2012, June 8). FDA approves Perjeta for type of late-stage breast cancer. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm307549.htm

    Wilson, S. (2012, June 8). FDA approves Perjeta (pertuzumab) for people with HER2-positive metastatic breast cancer. Retrieved from http://www.marketwatch.com/story/fda-approves-perjeta-pertuzumab-for-people-with-her2-positive-metastatic-breast-cancer-2012-06-08


Published On: September 10, 2013