By: Sophie Cousins
From: medscape.com
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has recommended granting a marketing authorisation for Palbociclib Viatris (palbociclib, Viatris Limited) for the treatment of locally advanced or metastatic breast cancer.
Palbociclib is a cyclin-dependent kinase 4/6 inhibitor designed to slow cancer cell proliferation for patients with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer.
It is used in combination with an aromatase inhibitor and with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone agonist.
Palbociclib Viatris is a generic of Ibrance, which has been authorized in the EU since late 2016.
Studies have demonstrated the satisfactory quality of the antineoplastic agent palbociclib and its bioequivalence to Ibrance. For example, the PALOMA trials demonstrated a statistically significant and clinically meaningful benefit in progression-free survival for palbociclib in combination with endocrine therapy (letrozole) compared with the placebo plus letrozole or letrozole alone in patients with HR-positive, HER2-negative advanced breast cancer.
Detailed recommendations for its use will be published by the EMA after the marketing authorization has been granted by the European Commission.
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