Palbociclib
Capsules: 125 mg, 100 mg, and 75 mg.
Palbociclib Capsule is a kinase inhibitor indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
letrozole as initial endocrine based therapy in postmenopausal women, or
fulvestrant in women with disease progression following endocrine therapy.
The indication in combination with letrozole is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.