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Precision Oncology Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

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 intended use will be in newly diagnosed ovarian cancer patients who are responsive to platinum chemotherapy regardless of biomarker status.

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.

CytoDyn will investigate the drug in 22 types of CCR5-positive locally advanced or metastatic solid tumors.  

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.