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?

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.