Treats early-stage HER2-positive breast cancer. NDA 208051, held by Puma Biotech. Neratinib Maleate.
As of Nov 14, 2026, NDA 208051 (Nerlynx), held by Puma Biotech, was first approved by FDA on Jul 17, 2017, with 7 approved supplements and 0 published complete response letters.
NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. 1.
| Jun 28, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jul 29, 2020 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Feb 25, 2020 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Feb 25, 2020 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Oct 1, 2019 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 17, 2017 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| NerlynxEQ 40MG BASE · tablet;oral | Neratinib Maleate | RxReference drug |
| Jun 28, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jul 29, 2020 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Feb 25, 2020 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Feb 25, 2020 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Oct 1, 2019 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Apr 18, 2019 | Supplement 3Labeling · Standard review | Approved | |
| Jun 28, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Jul 17, 2017 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
