Early FDA approval for Pfizer breast cancer drug Ibrance

Early FDA approval for Pfizer breast cancer drug Ibrance

Promising new breast cancer drug from Pfizer received federal approval early

The U.S. Food and Drug administration approved a Pfizer drug created for treatment of advanced breast cancer on Tuesday. The drug was pushed through a competitive accelerated approval program that allowed the high profile drug to be granted approval more than two months ahead of schedule. Pfizers Ibrance, chemical name palbociclib, was one of the most promising treatments in that pipeline. It is projected to generate annual sales upwards of $3 billion in five years, and is the first treatment advance in over 10 years for the specific type of cancer cell this drug has been designed to target.

Ibrance is for postmenopausal women that have been diagnosed with a specific type of cancer. These women cannot have taken other drugs or cancer treatments in the past. The receptors on the this type of cancer cell communicate through the membrane with estrogen, the female hormone, in the body and do not have mutations in the HER2 gene. Reports show that the HER2 gene contributes to uncontrolled development and progression of other aggressive types of  breast cancer cells.

Mace Rothenberg, head of oncology research and development for Pfizer, described Ibrance as “the first treatment advance for this group of women in more than 10 years.” This group of patients is the largest percentage of breast cancer cases that are prescribed the treatments chemotherapy tamoxifen or the estrogen production limiting drug letrozole.  Chief Executive Officer Ian Read said in a statement, “Today’s FDA approval has the potential to significantly impact the way oncologists treat thousands of women with advanced breast cancer across the U.S.”

The federally-approved drug has produced revolutionary results in safety studies performed at UCLA labs. The researchers there say the drug has the potential to become a chief supporting treatment for patients. The drug is to be used in conjunction with letrozole.

The National Cancer Institute estimates there were upwards of 232,600 breast cancer diagnoses among American women last year, 40,000 of whom died of the disease. Current government statistics report a decrease in deaths due to breast cancer over the last 20 years. Between 1990 and 2011, deaths went down 34 percent and experts speculate that the trend will continue into the future. This can be converted into more than 200,000 breast cancer deaths prevented says the American Cancer Society.

Pfizer estimated Ibrance will reach about 22,000 women a year as a viable treatment for those who have been diagnosed with advanced HER2-negative, ER-positive breast cancer. The company will charge $9,850 before discounts for quantities of the drug that can last a month.

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