FDA Approves Perejta, First Pre-Surgical Breast Cancer Drug

U.S. Food and Drug Administration (FDA) has approved the Roche drug, Perjeta, for pre-surgery in breast cancer patients.

This drug got a speedy approval from the FDA because of a  test  conducted on 417 women, who were treated with Perjeta in different combinations as a part of primary treatment for 12 weeks and the participants were found to have 18 percent higher chances of being cured from breast cancer in contrast to the women prescribed drugs followed before.

Medicines which show significant results for grave ailments are given speedy approvals.

This drug is expected to shrink the tumor and ease the surgical process of removal of the growth and lessen the chances of full mastectomy.  But long term impact of the drug is still unknown. The test was conducted on a small number, hence a follow-up study will be conducted on a larger population concentrating on the impact of the drug on the span and quality of the patients' life.

"By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences," FDA's Dr. Richard Pazdur, who directs the agency's office of cancer products, told Associated Press.

Around 4,800 patients have already been selected for a follow up study by Roche's Genentech unit based in San Francisco, California. The results for this study will be out in 2016.

Medics also believe that treating the tumor in the initial stage can prevent it from returning. Above 98 percent women can survive breast cancer for at least five years, if diagnosed with first-stage breast cancer, according to NCI (National Cancer Institute).

"This does not yet prove to us that using the antibody in this setting will result in more cures. That is still a hypothesis," said Dr. Paula Klein, a breast cancer specialist, who directs the breast cancer program at Continuum Cancer Centers of New York.

Perjeta has been approved by the FDA for treating metastatic cancer, which spreads to other body parts.

The drug Perjeta can only be given to patients diagnosed with tumors, which overproduce a protein known as HER-2. The protein triggers the growth of the cancer cells.

A course of Perjeta plus Herceptin would cost between $27,000 and $49,000, depending on how long the patient takes the combination, a spokeswoman for Genentech stated.