Roche makes case for early use of breast cancer drug in US
This article was originally published in Scrip
Roche’s breast cancer drug Perjeta appears to be effective and safe for early use in patients, US FDA staff said in a report.
The comments, included in briefing documents ahead of an FDA advisory panel this week, note that while more research is necessary to confirm early analysis, Roche’s study data make the case for a supplemental approval of the drug to treat women who have not received surgery.
Perjeta (pertuzumab) was approved in the US last year as a first-line treatment for HER2-positive metastatic breast cancer. Roche, through its biotechnology business Genentech, is seeking an accelerated approval of Perjeta for neoadjuvant treatment of breast cancer in combination with the company’s Herceptin (trastuzumab) and the chemotherapy docetaxel.
There are no approved therapies in the US for preoperative breast cancer but FDA officials say there is a need to treat patients earlier. Based on data presented by Genentech, Perjeta appears to be an option, FDA staff reviewers said. The drug can be used in combination with the other therapies to shrink tumors prior to surgery.
Study data, including research showing a survival benefit, “and the acceptable safety profile of pertuzumab supports the accelerated approval of a neoadjuvant indication,” the agency staff said in a report released September 10.
A recent survey of more than 200 cancer doctors by Datamonitor Healthcare found that some oncologists are already using the combination of Perjeta, Herceptin and docetaxel in early treatments. The survey included doctors in the US, Japan and Europe. (The drug gained EU and Japanese approval this year.)
“It is likely that Perjeta will gain some uptake in this treatment setting, although the high cost of treatment associated with the Herceptin-Perjeta combination is likely to limit use,” Datamonitor analyst Aine Slowey told Scrip.
The cost of the combination therapy would be around $27,000 to $49,000 per person depending on the length for a course of treatment, according to Genentech. The monthly cost of Perjeta is $5,900. Genentech has a patient access program to help women pay for the medicine.
The treatment would be designated for a specified amount of time, between nine and 18 weeks.
According to Genentech’s own analysis, an expanded approved use of Perjeta may add 15,000 patients in the US each year.
Study results for “Perjeta represent a meaningful benefit to people with HER2 positive early breast cancer and we look forward to Thursday’s discussion,” Genentech spokesperson Susan Wilson said.