Table 4. New drug/biologics license applications filed by manufacturer: August 16, 2014 through September 15, 2014.

Generic name Brand name (Company)	Comparative agents	Indication	Mechanism of action	Common adverse effects	Dosage form or route	Comments
Palbociclib (Pfizer)	None	Treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. Used in combination with letrozole.)	Selective cyclindependent kinases (CDKs) 4 and 6 inhibitor; results in improvement in cell cycle control and blocks tumor cell proliferation	Neutropenia, leukopenia, fatigue, and anemia	Oral	Classified as breakthrough therapy by the FDA
Rolapitant (TESARO)	Aprepitant	Prevention of chemotherapy-induced nausea and vomiting	Neurokinin-1 (NK-1) receptor antagonist	Fatigue, alopecia, and constipation	Oral and intravenous