Pfizer announced Thursday that the European Commission approved Ibrance (palbociclib), in combination with an aromatase inhibitor, for the treatment of women with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. The company noted that the drug is the first CDK 4/6 inhibitor to be authorised in the EU, and "is the first new medicine approved for the treatment of women with this type of metastatic breast cancer in the first-line setting in nearly 10 years."
Andreas Penk, regional president of international developed markets at Pfizer Oncology, remarked "with strong and consistent data in three pivotal clinical studies and rapid adoption as a standard of care in the US, Ibrance represents a potential new benchmark for the treatment of HR+/HER2- metastatic breast cancer." Ibrance was authorised in the US in 2015, with the company reporting earlier this month that sales of the product in the third quarter jumped more than two-fold to $550 million.
FirstWord reports in this therapy area - KOL Insight Breast Cancer: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
According to Pfizer, the approval by the European Commission also covers use of Ibrance in combination with AstraZeneca's Faslodex (fulvestrant) in women who have received prior endocrine therapy. The decision was based on results from the Phase II PALOMA-1 trial in postmenopausal women with oestrogen receptor-positive, HER2-negative metastatic breast cancer who had not received prior systemic therapy for their advanced disease, the Phase III PALOMA-2 study in the same population and the Phase III PALOMA-3 trial in women with hormone receptor-positive, HER2-negative metastatic breast cancer who had progressed on prior endocrine therapy.
Results from all three studies demonstrated that Ibrance in combination with an endocrine therapy significantly prolonged progression-free survival compared to endocrine therapy alone or endocrine therapy with placebo. For related analysis, see Physician Views Poll Results: Pfizer's breast cancer drug Ibrance primed for strong EU5 launch.
Earlier this month, Novartis announced that the FDA granted priority review to the company's marketing application seeking approval of its CDK 4/6 inhibitor ribociclib as a first-line treatment for postmenopausal women with hormone-receptor positive, HER2-negative advanced or metastatic breast cancer in combination with Femara (letrozole). The European Medicines Agency has also accepted for review a filing seeking approval of the drug in the same indication (for further analysis, read ViewPoints: Can Novartis turn up the pressure on Pfizer's Ibrance?).
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