Alectinib Hydrochloride

Treats ALK-positive metastatic NSCLC. Sold as Alecensa. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Alectinib Hydrochloride (sold as Alecensa), first approved Dec 11, 2015, with 3 new uses approved and 0 published complete response letters.

First approved: Dec 11, 2015
Applications: 1
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $387M
Orphan exclusivity until: Apr 18, 2031
First approved in the EU: Feb 16, 2017
First approved in Japan: Jul 4, 2014

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Alecensa	Part D	$387M	+57%	2,662

Orphan Designations (FDA)

3 designations, 3 approved for the designated use; see all orphan designations

Treatment of ALK-positive non-small cell lung cancerHoffmann-La Roche, Inc. (c/o Genentech, Inc.) · designated Jan 27, 2015 · approved Nov 6, 2017
Treatment of ALK-positive non-small cell lung cancerHoffmann-La Roche, Inc. (c/o Genentech, Inc.) · designated Jan 27, 2015 · approved Apr 18, 2024 · exclusive to Apr 18, 2031
Treatment of ALK-positive non-small cell lung cancerHoffmann-La Roche, Inc. (c/o Genentech, Inc.) · designated Jan 27, 2015 · approved Dec 11, 2015

Approvals in the EU (EMA)

First approved in the EU 14 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Alecensa, new substanceRoche Registration GmbH · Feb 16, 2017

Approvals in Japan (PMDA)

First approved in Japan 17 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

AlecensaA drug with a new indication, a new dosage, and other characteristics for the postoperative adjuvant treatment for anaplastic lymphoma kinase (ALK ) fusion… · Chugai Pharmaceutical Co., Ltd. · Aug 28, 2024
AlecensaA drug with a new indication and a new dosage for the treatment of relapsed or refractory ALK fusion gene-positive anaplastic large cell lymphoma. · Chugai Pharmaceutical Co., Ltd. · Feb 21, 2020
Alecensa, new ingredientDrugs with a new active ingredient indicated for the treatment of unresectable advanced/relapsed ALK fusion gene-positive non-small-cell lung cancer. · Chugai Pharmaceutical Co., Ltd. · Jul 4, 2014 · Review report

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide PolymorphismsALK-Positive Non-Small Cell Lung Cancer (NSCLC) · Medicine Invention Design, Inc	Phase 2 / Phase 3	Active, not recruiting	Aug 14, 2023
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors IISolid Tumor, Advanced Solid Tumor · Seoul National University Bundang Hospital	—	Active, not recruiting	Sep 2, 2022
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic ProfilingCancer, Tumors · Ulrik Lassen	Phase 2	Recruiting	Apr 10, 2020
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic MutationNon Small Cell Lung Cancer, EGFR Gene Mutation · Hunan Province Tumor Hospital	Phase 2	Recruiting	Mar 26, 2020
The Drug Rediscovery Protocol (DRUP Trial)Cancer, Tumors · The Netherlands Cancer Institute	Phase 2	Recruiting	Oct 5, 2016

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 11, 2015	AlecensaNDA 208434 · New molecular entity	Hoffmann-La Roche	8	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA