Breast Cancer Drug Perjeta Gets FDA Approval
June 12, 2012 § Leave a Comment
A new drug has been approved by the U.S. Food and Drug Administration for the fight against breast cancer. Generically known as pertuzumab, Perjeta, which is marketed by bio-tech drug maker Roche Holding AG, is indicated to treat people with an aggressive, late-stage breast cancer that is known as HER-2 positive.
HER-2 positive breast cancer has no known cure, and makes up about 25 percent of all breast cancer.
In clinical trials, Perject kept the breast cancer from getting worse for an extra six months, compared to current treatments. Also in clinical trials, women who combined Perjeta with chemotherapy and Herceptin (another Roche breast cancer drug), had 18.5 months sans tumor growth, compared to 12.4 months in women whose treatment consisted of older drugs.
To determine the drug’s safety and effectiveness, 808 people with HER-2 positive breast cancer were followed in a clinical study. Side effects were noted, with the most common being hair loss, rash, nerve damage, diarrhea, nausea, fatigue, and a decrease in white blood cells.
Because the FDA approved the drug with a “black box” label, a woman must have here pregnancy status verified before she starts using Perjeta. A black box label warning means that there is a potential for severe effects, including death of an unborn fetus.
Because the FDA believes Perjeta may have a potential substantial advancement over current treatment, the FDA accepted Perjeta’s application under a priority review.
Analysts predict the injectable drug Perjecta could be the next blockbuster cancer drug for Roche, a Swiss pharmaceutical company.
In a poll of analysts by Thomason Reuters, analyst predict on average annual sales of pertuzumab to reach over 600 million by 2016. And some experts suggest sales could climb to over $1 billion.
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