According to Pfizer, the decision makes Ibrance (palbociclib) the first medicine that works by inhibiting cyclin-dependent kinases 4 and 6, which interferes with the division of cancer cells and helps stop tumour growth, to win approval in Europe.
It is also 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, the firm said.
Approval is based on a package of clinical data from three randomised trials demonstrating that Ibrance in combination with an endocrine therapy significantly prolonged progression-free survival compared to endocrine therapy alone or endocrine therapy with placebo.
In one late-stage trial, patients who received Ibrance lived on average 24.8 months without their disease getting worse, compared to 14.5 months in those taking letrozole.
“Palbociclib is an exciting advance in the management of women with hormone receptor-positive breast cancer,” said Nicholas Turner, team leader at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, as well as principal investigator of the PALOMA-3 trial.
“Patients with this type of breast cancer are usually treated with hormone therapy but many will progress or relapse – and as a result require chemotherapy, which often comes with life-limiting side-effects. Palbociclib, when used in combination with standard hormone therapy, increases the duration of tumour control and is well tolerated by most women – and could delay the need for women with this type of advanced breast cancer to start chemotherapy.”