Subsequent Events |
12 Months Ended |
---|---|
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events |
Note 16—Subsequent Events:
On February 25, 2020, the FDA approved a supplemental New Drug Application, or sNDA, for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens. |