The FDA had previously approved neratinib as an extended adjuvant therapy for patients with early-stage HER2-overexpressed or amplified breast cancer, following adjuvant treatment with trastuzumab.
The company is seeking to expand the use of the drug as a first-line treatment after it received accelerated approval from the FDA in 2017 for those who failed on Xalkori.
The application for Tecentriq as a first-line monotherapy for NSCLC patients without EGFR or ALK mutations and high PD-L1 expression was also granted priority review.
