At the beginning of September a group of experts, the FDA’s Oncologic Drugs Advisory Committee (ODAC), recommended accelerated approval of the Genentech’s drug Perjeta (Pertuzumab) for neoadjuvant treatment of early stage Her-2 positive breast cancers.
The Committee voted 13 to 0 with one abstention for the approval of Perjeta in combination with other two drugs, docetaxel and trastuzumab, another Genentech drug against Her-2. The FDA will return a verdict before the end of October. If approved, Perjeta is going to be the first nation’s cancer drug used to treat cancer patients before surgery with the purpose of shrinking the tumor to make it operable and allow breast conserving surgery.
Perjeta was approved by FDA in 2012 to treat metastatic HER-2 positive breast cancers after surgery. It is an antibody that binds to the Her-2 receptor inhibiting its activity by preventing the binding with other members of the Her-2 family.
The panel of experts based their decision on three clinical trials, two Phase II trials (NEUROSPHERE and TRYPHAENA) involving early breast cancer patients, and a Phase III trial (CLEOPATRA) with metastatic breast cancer patients. The NEUROSPHERE and TRYPHAENA were both conducted on patients with early stage Her-2 positive breast cancer, using two different regimen of chemotherapy. NEUROSPHERE used Perjeta and Herceptin in combination with docetaxel, and TRYPHAENA used Perjeta and Herceptin in combination with anthracycline. The pathological complete response (pCR) was improved in both trials in patients using Perjeta in combination with the other drugs. The increased efficacy of Perjeta combined with Herceptin is probably due to the binding of the two antibodies to two different regions of the Her-2 receptor, thus synergistically inhibiting its activation.
20% of breast cancer patients are Her-2 positive and those are the ones who are going to benefit from this treatment. This kind of tumor is very aggressive with 6,000 women dying every year in the US, mainly because of its inoperability. This drug will help to decrease the tumor volume, thus making it operable.
Genentech is part of the big Swiss pharmaceutical company Roche. Genentech has spent more than 30 years studying breast cancer leading to the commercialization of the first drug approved to treat Her-2 positive breast cancers, Herceptin. Genentech is going to lose the patent exclusivity for Herceptin in 2014 in Europe and 2018 in the US. Probably this market will be replaced by Perjeta…
This drug will treat breast cancer and Genentech’s budget.