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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › Puma's Neratinib sNDA Approved by FDA for HER2-Positive Metastatic Breast Cancer

Puma's Neratinib sNDA Approved by FDA for HER2-Positive Metastatic Breast Cancer

Feb 27, 2020
|
staff reporter

NEW YORK – Puma Biotechnology said on Wednesday that the supplemental new drug application of neratinib (Nerlynx) in combination with chemotherapy capecitabine was approved by the US Food and Drug Administration. The approved indication is for advanced or metastatic HER2-positive breast cancer patients who have received two or more anti-HER2 therapies prior.

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