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The agency has recommended marketing authorization for Ibrance in the European Union.
The European Medicines Agency (EMA) announced on Sept. 16, 2016 that it was recommending that Ibrance, a treatment for locally advanced or metastatic breast cancer, be granted marketing authorization in the European Union. According to EMA, the drug has been used to treat cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative.
EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug based on two Phase III trials. One study compared treatment with palbociclib and letrozole, an aromatase inhibitor, with letrozole treatment alone. Four hundred and forty-four patients lived on average 24.8 months without their disease getting worse, compared to 14.5 months in the group of 222 patients that received letrozole alone. The other trial compared treatment of fulvestrant together with palbociclib to treatment with only fulvestrant. Preliminary results showed that 347 out of 521 patients who received palbociclib had an average of 11.2 months without their disease getting worse compared to 4.6 months for 174 patients who only received fulvestrant.
Ibrance (palbociclib) blocks cyclin-dependent kinases (CDK) 4 and 6 protein, which inhibits cancer cells and tumor growth. It is used in postmenopausal women in combination with an aromatase inhibitor or with fulvestrant for women who have undergone hormone therapy. For premenopausal women, the hormone therapy is combined with a luteinizing hormone releasing hormone (LHRH).