Alecensa

Treats ALK-positive metastatic NSCLC. NDA 208434, held by Hoffmann-La Roche. Alectinib Hydrochloride.

As of Nov 14, 2026, NDA 208434 (Alecensa), held by Hoffmann-La Roche, was first approved by FDA on Dec 11, 2015, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 11, 2015
Review: Priority
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Jun 11, 2026	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 18, 2024	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Nov 6, 2017	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 11, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
AlecensaEQ 150MG BASE · capsule;oral	Alectinib Hydrochloride	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Aug 14, 2026	Supplement 17Labeling · Standard review	Approved	Label Letter
Jun 11, 2026	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 18, 2024	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Sep 3, 2021	Supplement 12Labeling · Standard review	Approved	Label Letter
Jan 29, 2021	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 5, 2018	Supplement 4Labeling · Standard review	Approved	Letter Letter Label
Nov 6, 2017	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 4, 2016	Supplement 1Labeling · Standard review	Approved	Letter Label
Dec 11, 2015	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Label

Identifiers

Application: NDA 208434
Drugs@FDA: Overview at FDA
Company: Hoffmann-La Roche

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