Treats operable node-positive BC Non-small Cell Lung Cancer (NSCLC). NDA 215813, held by Avyxa Holdings. Docetaxel.
As of Nov 14, 2026, NDA 215813 (Docivyx, Docetaxel), held by Avyxa Holdings, was first approved by FDA on Nov 22, 2022, with 3 approved supplements and 0 published complete response letters.
DOCIVYX is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC Castration- Resistant Prostate Cancer (CRPC): with prednisone in metastatic CRPC Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction Squamous Cell Carcinoma of the Head and Ne…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Jan 17, 2025 | Supplement 3Manufacturing | Approved | |
| Apr 11, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Apr 11, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Nov 22, 2022 | Original applicationNew formulation or manufacturer · 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
