UPDATED: Roche wins blockbuster OK for combo breast cancer drug pertuzumab

Roche's cancer drug franchise is adding a significant new breast cancer treatment to the portfolio. The company's Genentech subsidiary announced last night that the FDA had handed out an approval for pertuzumab, setting the stage for a new combo attack on HER2-positive cases. The drug will be sold as Perjeta at a cost of $5,900 a month, or about $71,000 a year, according to a spokesperson for Genentech. 

In clinical studies investigators found that pertuzumab added to the pioneering Herceptin (trastuzumab) and chemo extended progression-free survival rates in patients by an average of 6.1 months--with a median PFS rate of 18.5 months versus 12.4 in the Herceptin-plus-chemo-only arm. The drug will be available to patients in two weeks.

The approval is particularly noteworthy for several reasons. The OK underscores investigators' growing understanding of targeting cancer from different angles, extending the survival rates of even the sickest patients. Pertuzumab originally failed to impress as a standalone drug, emerging as a blockbuster contender only after it was combined with Herceptin. The approval also highlights the way cancer is being divvied into various subpopulations; about a quarter of all breast cancer cases are HER2-positive. The priority review provided by the FDA underscores the agency's avid interest in accelerating approvals for new cancer drugs that fit these guidelines. The pertuzumab approval also sets the stage for a likely approval of T-DM1, a Roche/ImmunoGen "armed antibody" that has also demonstrated impressive PFS rates in a late-stage study.

But with the blockbuster Herceptin earning close to $6 billion a year with a price tag of $4,500 a month, or $54,000 a year, there's likely to be a new round of discussion over how much payers can afford. "Most patients will take the combination of Perjeta and Herceptin until their disease worsens," notes a spokesperson, "which is about 18 months. The estimated cost for a course of treatment with Perjeta and Herceptin for 18 months is approximately $188,000." Analyst estimates for peak sales of pertuzumab range from more than $600 million a year to more than a billion dollars annually.

"Based on the way the two medicines work together, the combination plus chemotherapy can prolong the time before this aggressive cancer worsens compared to Herceptin and chemotherapy alone," noted Hal Barron, Genentech's CMO. "We are very pleased to see our efforts in studying the science of HER2 translate into another personalized medicine."

- here's the press release
- read the Reuters story