Scemblix

NDA 215358, held by Novartis. Asciminib Hydrochloride.

As of Nov 14, 2026, NDA 215358 (Scemblix), held by Novartis, was first approved by FDA on Oct 29, 2021, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 29, 2021
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Nov 25, 2025	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Letter Label
Oct 2, 2025	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 29, 2024	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 29, 2024	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 12, 2022	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 29, 2021	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label
Oct 29, 2021	Original applicationNew molecular entity · Priority review	Approved	Letter Label

Products

3 strengths and forms


ScemblixEQ 20MG BASE · tablet;oral	Asciminib Hydrochloride	RxReference drug
ScemblixEQ 40MG BASE · tablet;oral	Asciminib Hydrochloride	RxReference drug
ScemblixEQ 100MG BASE · tablet;oral	Asciminib Hydrochloride	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Sep 22, 2026	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 14, 2026	Supplement 14Manufacturing	Approved	Letter Label
Nov 25, 2025	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Letter Label
Oct 2, 2025	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 29, 2024	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 29, 2024	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 7, 2024	Supplement 7Labeling · Standard review	Approved	Letter Label
Jun 18, 2024	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 8, 2023	Supplement 4Labeling · Standard review	Approved	Letter Label
Jun 26, 2023	Supplement 3Labeling · Standard review	Approved	Label Letter
Oct 12, 2022	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 29, 2021	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label
Oct 29, 2021	Original applicationNew molecular entity · Priority review	Approved	Letter Label

Identifiers

Application: NDA 215358
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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