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FDA Approves Pfizer’s New Breast Cancer Drug

| February 3, 2015 Comment

FDA Approves Pfizer’s New Breast Cancer Drug – The US Federal Drug Administration (FDA) has approved a new breast cancer drug for treating aggressive and advanced breast cancer in postmenopausal women.

Called IBrance (palbociclib), the drug is for women who have tumors that do not contain a protein known as HER-2 and have not received an endocrine-based therapy. HEr-2 causes cancerous cells to divide and grow faster.

Preliminary clinical trials have shown that Pfizer’s IBrance slowed the progression of breast cancer. In studies, women taking Ibrance and letrozole lived 20.2 months on average before their tumors worsened, which was twice as long compared to those taking only  letrozole.

FDA approved Ibrance under its accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug offers clinical benefit to patients. The program also provides early access to such drugs to patients.

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