FDA Green Lights Pfizer's High Profile Breast Cancer Drug Two Months Early

February 4, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration (FDA) announced on Feb. 3 that it had approved of Ibrance, also known as palbociclib, for the treatment of metastatic breast cancer. This comes two months before the FDA was slated to complete its review of the drug in April.

Ibrance works by inhibiting cyclin-dependent kinases 4 and 6, which are involved in promoting the growth of cancer cells. The drug is intended for use in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer who have not received an endocrine-based therapy.

“The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to expediting marketing approval of cancer drugs through our accelerated approval regulations.”

Ibrance was approved under the FDA’s accelerated approval program, which permits the approval of drugs designed to treat life-threatening diseases. In this program, there is earlier patient access as the new drug goes through clinical trials.

The most common side effects of the drug identified thus far are a decrease in the body’s ability to fight infection, low levels of white blood cells, fatigue and low red blood cell counts. Additionally, some patients showed signs of nausea, upper respiratory infection, hair loss and diarrhea. Currently, Ibrance is being recommended to individuals at a starting dose of 125 milligrams for 21 days.

Promising Study Results
In December 2014, Pfizer Inc. released the results of its PALOMA-1 study, a Phase II trial designed to determine the impact of palbociclib in combination with letrozole versus letrozole alone. PALOMA-1 achieved its primary endpoint, significantly prolonging the progression-free survival rate. The results were published in The Lancent Oncology journal.

“The publication of the PALOMA-1 data in The Lancet Oncology marks another important milestone in the path to bring IBRANCETM, the proposed trade name for palbociclib, to women with ER+, HER2- metastatic breast cancer, who haven’t seen a first-line treatment advance in more than 10 years,” said Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology.

Additionally, Lead Author Richard Finn presented the results of the study at the American Association for Cancer Research’s Annual Meeting in 2014.

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