This article originally appeared on recnac.org.

The FDA recently approved the drug Perjeta (bertuzumab). Perjeta is intended for patients with early-stage breast cancer before surgery in neoadjuvant settings. Perjeta is the first treatment drug that the Food and Drug Administration approved for good neoadjuvant therapy for breast cancer.

In 2012, it was for patients with accelerated or late-stage (metastasis) HER2-positive breast cancer. That certain cancer have inflated sums of the HER2 protein that adds to cancer cell growth and survival. Now, the drug is strictly for the patients with HER2-positive, locally-accelerated, inflammatory, or the early-stage breast cancer.

In those cases, the tumors are greater than 2 cm in diameter or the positive lymph nodes are present. Those individuals are at high risk of remission, metastasize, and, in some cases, death. Perjeta should be utilized in combination with trastuzumab and other chemotherapies before surgery.

The drug can be utilized after surgeries with more chemotherapies, but that depends on the therapy regimens. Then, the patient will need to keep taking trastuzumab in order to finish one year of therapy. The FDA’s accelerated approval program gives patients access to promising drugs to treat serious, or life-threatening conditions while the confirmatory clinical trials are going on.

A study was done to measure the pCR that included 417 patients. Those patients were given one of the four neoadjuvant treatment regimens. Each patient was chosen to randomly to get one of the four kinds of therapies. It was either the Perjeta plus the trastuzumab, Perjeta plus docetaxel, trastuzumab plus docetaxel, or Perjeta plus trastuzumab and docetaxel.

It was found that close to 39% of the participants who were given Perjeta plus trastuzumab and docetaxel achieved pCR. Close to 21% of the cancer patients who were given the trastuzumab plus the docetaxel accomplished pCR. It is for these reasons that Perjeta got approved so quickly by the Food and Drug Administration.

There is a confirmatory trial for that drug still occurring. Over 4,800 patients are apart of it too. They have HER2-positive breast cancers, have had breast cancer surgeries before, and are at high risk of having their cancers come back. The trial will end in 2016, and the study conductors will get more info regarding efficacy, safety, and long-term outcomes.

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