U.S. pharmaceutical giant Pfizer Inc. (PFE
) announced that it has secured approval from the U.S. Food And Drug Administration (FDA) for a supplemental New Drug Application (sNDA) for its first-in-class cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, Ibrance (palbociclib). The sNDA approval has converted the accelerated approval of the breast cancer drug to a regular approval, and has widened the scope of anti-hormonal therapy that may be administered with the drug.
Ibrance, in combination with letrozole, first secured accelerated approval in February 2015 for treating advanced breast cancer. That was followed by another approval in February 2016 in combination with fulvestrant for treating women with disease progression following endocrine therapy. The recent FDA decision has approved Ibrance as a first-line therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive (ER+), HER2- metastatic breast cancer.
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