Treats advanced gastrointestinal stromal tumor (GIST). NDA 213973, held by Deciphera Pharms. Ripretinib.
As of Nov 13, 2026, NDA 213973 (Qinlock), held by Deciphera Pharms, was first approved by FDA on May 15, 2020, with 5 approved supplements and 0 published complete response letters.
QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Qinlock50MG · tablet;oral | Ripretinib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 6, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Oct 26, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Dec 29, 2022 | Supplement 4Labeling · Standard review | Approved | |
| Sep 15, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Jun 17, 2021 | Supplement 1Labeling · Standard review | Approved | |
| May 15, 2020 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
