Puma Biotechnology announces U.S. FDA acceptance of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer

Puma Biotechnology

11 September 2019 - Puma Biotechnology announced that the U.S. FDA has accepted for review its supplemental new drug application for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy (third-line disease). 

The FDA has informed the Company that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA confirmed that the review will have an action date of late April, 2020.

The application is supported by the results of the Phase III NALA trial, a randomised controlled trial of neratinib plus capecitabine versus Tykerb (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer.

Read Puma Biotechnology press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier