Nerlynx (neratinib) fda approval history drugs.com?

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Nerlynx® (neratinib) – FDA approval timeline

Year	FDA action	Key details
2017	First FDA approval	23 Feb 2017 – Neratinib was approved as an oral, small‑molecule irreversible pan‑HER family tyrosine kinase inhibitor for patients with HER2‑positive metastatic breast cancer who have progressed on trastuzumab and a HER2‑targeted therapy (e.g., lapatinib). The approval was granted via the accelerated‑approval pathway based on the Phase 2 NALA trial showing improved overall survival over lapatinib‑capecitabine.
2018	Combination with capecitabine	1 Feb 2018 – FDA approved Neratinib in combination with capecitabine for patients with HER2‑positive metastatic breast cancer who had progressed on prior trastuzumab‑based therapy and a HER2‑targeted TKI. This was a post‑approval labeling change following the NALA trial’s combination arm.
2022	Adjuvant therapy	25 Apr 2022 – FDA approved Neratinib for use as adjuvant therapy in patients with early‑stage, HER2‑positive breast cancer who have received 1–2 years of adjuvant trastuzumab‑based therapy (with or without pertuzumab). The indication is for patients who are ≥18 years and have completed a full course of trastuzumab‑based therapy. This approval followed the HER2CLIMB study, which demonstrated a 10‑month improvement in invasive disease‑free survival.
2023	Label update	17 Oct 2023 – FDA updated the prescribing information to include a new “Drug Interaction” section and a revised dosing schedule for patients who experience diarrhea (the most common adverse event).

How to find the full FDA history

FDA’s Drugs@FDA database – Search “neratinib” or “Nerlynx” to view all approvals, labeling changes, and safety information.
FDA’s MedWatch – For post‑marketing safety reports and adverse event data.
Drugs.com – The site’s “Drug Details” page for Nerlynx lists FDA approval dates, indications, and regulatory history, pulling data from the FDA and other regulatory bodies.

Bottom line: Neratinib received its initial FDA approval in 2017 for HER2‑positive metastatic breast cancer, expanded to a combination with capecitabine in 2018, and was later approved as adjuvant therapy for early‑stage HER2‑positive breast cancer in 2022, with ongoing label updates to improve safety and dosing.

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Nerlynx (neratinib) fda approval history drugs.com?

How to find the full FDA history