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

FDA to Review Nerlynx Combo as Third-line Treatment for HER2-positive Metastatic Breast Cancer
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 company has announced. The supplemental New Drug Application (sNDA) is for women who have failed two or more prior lines of HER2-targeted therapy. A decision is expected by April 2020. “The FDA’s acceptance of our sNDA marks another important regulatory milestone for my team,” Alan H. Auerbach, CEO and president of Puma, said in a news release. “We look forward to working with the FDA during its review of this submission, which targets patients with HER2-positive metastatic breast cancer who have progressed on two or more prior treatments and who need additional treatment options,” he added. Puma's application is based on data from the NALA Phase 3 trial (NCT01808573), which showed that
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