FDA approves Roche's pricey new Herceptin partner, Perjeta

Roche ($RHHBY) has added another targeted breast cancer drug to its oncology quiver. The FDA approved its new treatment for  HER2-positive disease, pertuzumab, now dubbed Perjeta. It's a potential blockbuster, with analyst estimates running $600 million to $1 billion-plus and impressive progression-free survival data. With a couple of additional indications now under study, Perjeta could climb to peak sales of $8.5 billion, Jeffries analysts have said.

And it won't cannibalize the standard HER2 treatment Herceptin, because it's designed for use in tandem with the older drug. Perjeta and Herceptin are aimed at different regions of the HER2 receptor, so the combination can hit HER2-positive cancer with a one-two punch. The two drugs would be used along with Sanofi's ($SNY) Taxotere, also available as a generic. And Perjeta is a potential partner for Roche's up-and-coming Herceptin-plus drug, T-DM1, which played a starring role at the American Society of Clinical Oncology meeting earlier this month.

The only drawback: price. In the oncology market, where drug costs are skyrocketing, the Perjeta-plus-Herceptin combination still stands out. The sticker price on Perjeta is $5,900 a month, or about $71,000 a year, Genentech says. Herceptin's price tag is $4,500 a month, or $54,000 a year. That's $115,000 for a year's worth of treatment.

But the combo is likely to be used for longer than that, a Genetech spokesperson told FierceBiotech. "Most patients will take the combination of Perjeta and Herceptin until their disease worsens, which is about 18 months," the spokesperson said. "The estimated cost for a course of treatment ... for 18 months is approximately $188,000."

Thus, Perjeta neatly encapsulates a conundrum in the cancer-drug business. It's a targeted drug designed as part of a combination, something that other drugmakers are aiming to do; think of Roche's melanoma drug Zelboraf now being studied in combination with Bristol-Myers Squibb's ($BMY) Yervoy. These targeted combinations could offer big improvements for patients.

But they're also sure to be pricey--$188,000 for a treatment course is impressive by any standard--and so payers may balk, cuing public outcry. "The rising cost of medical care--and cancer care in particular--is not sustainable and must be addressed by the medical community," ASCO President Michael P. Link said during his speech at the annual meeting. Drugs are only a part of that cost, to be sure. But drug prices will have to be part of that conversation.

- read the Genentech release
- get more from International Business Times
- see the coverage from Reuters
- read Link's speech
- check out FierceBiotech's take