Ibrance Approved in the European Union


Ibrance has received approval from the European Commission to treat metastatic breast cancer.

Pfizer recently announced that the European Commission has approved Ibrance (palbociclib) in combination with an aromatase inhibitor for the first-line treatment of patients with breast cancer.

Ibrance is also indicated in combination with fulvestrant in patients who have received previous treatment with endocrine therapy.

The drug is the first CDK 4/6 inhibitor to be approved in Europe, Pfizer reported in a press release. It is also the first new treatment approved for women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer in almost a decade.

“Today’s approval of Ibrance in the European Union brings an innovative and much-needed new treatment option to tens of thousands of women with HR+/HER2- metastatic breast cancer,” said Andreas Penk, MD, regional president, International Developed Markets, Pfizer Oncology. “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 in Europe.”

These patients account for approximately 60% of all metastatic breast cancer diagnoses, and this recent approval further highlights the need for more research and treatment options for these patients.

This latest approval is based on a submission package that includes pivotal results from PALOMA-1, a phase 2 clinical trial that included treatment-naïve postmenopausal patients with estrogen receptor-positive (ER+)/HER2- metastatic breast cancer, and PALOMA-2, a phase 3 clinical trial in the same patient population, according to Pfizer.

Also included in the submission package was results from the phase 3 PALOMA-3 trial in patients with HR+/HER2- metastatic breast cancer. Findings from all 3 trials suggested that Ibrance combined with an endocrine therapy increased progression-free survival compared with endocrine monotherapy or endocrine therapy plus placebo.

“Palbociclib is an exciting advance in the management of women with hormone receptor-positive breast cancer. 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,” said Nicholas Turner, MD, PhD, 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. “Palbociclib, when used in combination with standard hormone therapy, increases the duration of tumor 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.”

In Europe, breast cancer is the most common invasive cancer in women, with up to 30% of women diagnosed with early stage disease will progress to metastatic disease. Currently, there is no cure for metastatic breast cancer, and patients need new treatment options to help them refrain from progressing, manage symptoms, and improve quality of life — Pfizer hopes to do just that with the recent approval.

“Metastatic breast cancer patients in Europe need new treatment options available to them,” said Kathi Apostolidis, two-time breast cancer survivor and vice president of the European Cancer Patient Coalition. “Metastatic breast cancer places a heavy burden on cancer patients and their families, but patients hope that novel treatments may have the potential to provide better quality of life and outcomes.”

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