Faster approval of Roche’s drug for early stage breast cancer, Perjeta, is supported by trial data, reviewers for the US Food and Drug Administration have announced this week.
The Swiss pharmaceutical company is seeking approval of Perjeta as a neoadjuvant, which is a therapeutic agent administered before a main treatment, for patients whose cancer cells contain increased amounts of HER2 protein, but are still in the early stages of the disease.
Perjeta, also known as pertuzumab, is already approved as a first-line treatment for metastatic breast cancer.
For early stage breast cancer, the drug would be administered along with Roche’s other cancer drug, Herceptin, and chemotherapy drug docetaxel.
If the drug is approved, it will become the first neoadjuvant breast cancer treatment approved by the FDA. The agency is trying to set up a new faster approvals process for early-stage breast cancer treatment.
This includes a proposed new clinical goal known as pathologic complete response (pCR), which is defined as absence of invasive cancer in the breast.
"FDA analysis of the Neosphere study showed statistically significant improvements in pCR rates by both the study and FDA-preferred definitions," FDA staff said, reports Reuters.
Dietmar Berger, vice president of clinical development at Roche’s Genentech unit, is reported by the news agency as saying that if Perjeta is considered in the neoadjuvant setting under the pCR pathway then it could be approved four years earlier than if the company were asked to wait for data from an ongoing trial not expected until 2016.
An estimated 220,000 people are diagnosed with early breast cancer in the US each year.
Image: If the drug is approved, it will become the first neoadjuvant breast cancer treatment approved by the FDA. Photo: courtesy of Foxumon.
