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Data Support Fast Approval of Breast Cancer Drug Perjeta (Pertuzumab)

FDA advisors consider first neoadjuvant breast cancer treatment (September 10)

The FDA’s Oncologic Drugs Advisory Committee has ruled that clinical trial data on the breast cancer treatment Perjeta (pertuzumab) support accelerated approval for use in early stages of the disease.

Pertuzumab is a monoclonal antibody that targets the extracellular domain (subdomain II) of the human epidermal growth factor receptor 2 (HER2) protein. Perjeta (pertuzumab) was approved in June 2012 and is indicated for use in combination with the older breast cancer drug Herceptin (trastuzumab, Roche) and the chemotherapy drug docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

The drug’s developer (Genentech) is now seeking approval for Perjeta as a neoadjuvant, or initial, treatment for early-stage breast cancer patients whose cancer cells contain increased amounts of the HER2 protein.

The new regulatory application is supported by data from the NEOSPHERE trial, a pivotal randomized study designed to evaluate four neoadjuvant regimens in 417 patients with operable, locally advanced, or inflammatory HER2-positive breast cancer. The patients were randomly assigned to receive one of four neoadjuvant regimens prior to surgery: trastuzumab plus docetaxel (n = 107); pertuzumab plus trastuzumab and docetaxel (n = 107); pertuzumab plus trastuzumab (n = 107); or pertuzumab plus docetaxel (n = 96). The main comparison was trastuzumab plus docetaxel (control) versus pertuzumab plus trastuzumab and docetaxel (experimental).

Pathological complete response (pCR) rates were 21.5% for the group treated with pertuzumab plus trastuzumab versus 39.3% for the group treated with pertuzumab plus trastuzumab and docetaxel (P = 0.0063).

A panel of independent advisors to the FDA will review Perjeta’s risks and benefits on September 12, and the agency is expected to make a final decision by October 31.

If approved, Perjeta — in combination with trastuzumab and docetaxel — would be the first neoadjuvant breast cancer treatment in the U.S.

Sources: Reuters; September 10, 2013; and FDA; September 2013.

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