supplemental New Drug Application

September 13, 2019September 13, 2019

FDA to Review Nerlynx Combo as Third-line Treatment for HER2-positive Metastatic Breast Cancer

News

The U.S. Food and Drug Administration (FDA) has agreed to review Puma Biotechnology’s application seeking approval of Nerlynx (neratinib), in combination with capecitabine, to treat HER2-positive breast cancer patients with metastatic disease, the ... Read more

July 8, 2019

Puma Applies to FDA to Extend Nerlynx’s Use to HER2-Positive Metastatic Breast Cancer

News

Puma Biotechnology is seeking to extend the use of its breast cancer medicine Nerlynx (neratinib), in combination with capecitabine, to treat women with HER2-positive breast cancer whose disease has spread ... Read more

January 3, 2017January 3, 2017

FDA Reviewing Ibrance Combo as Standard Therapy for Metastatic Breast Cancer

News

The U.S. Food and Drug Administration (FDA) is reviewing a request that Ibrance (palbociclib), in combination with Femara (letrozole), be used as a first-line therapy for postmenopausal women with estrogen receptor-positive, human epidermal growth ... Read more