Related Experiment Video

Updated: Apr 27, 2026

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
08:36

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

Published on: April 7, 2023

1.8K

Ceritinib: first global approval

Sohita Dhillon1, Madeleine Clark

  • 1Adis, Level 1, 5 The Warehouse Way, Northcote, 0627, Auckland, New Zealand, dru@adis.com.

Drugs
|July 2, 2014
PubMed

Insights

Ceritinib, an anaplastic lymphoma kinase (ALK) inhibitor, is now approved for advanced ALK-positive non-small cell lung cancer (NSCLC) after crizotinib treatment. This marks a significant milestone in targeted cancer therapy.

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Anaplastic lymphoma kinase (ALK) is a tyrosine kinase that can drive cancer when abnormally fused with other proteins.
  • ALK rearrangements are key drivers in a subset of non-small cell lung cancer (NSCLC).
  • Targeted therapies inhibiting ALK have transformed treatment paradigms for ALK-positive NSCLC.

Purpose of the Study:

  • To summarize the development milestones of ceritinib.
  • To highlight the first approval of ceritinib for specific NSCLC patients.
  • To provide an overview of ceritinib's role in ALK-positive NSCLC treatment.

Main Methods:

  • Review of clinical development data for ceritinib.
  • Summary of regulatory submissions and approvals.
  • Analysis of ceritinib's efficacy in patients with ALK-positive metastatic NSCLC.

Main Results:

  • Ceritinib received US FDA approval as a second-line treatment for ALK-positive metastatic NSCLC.
  • The drug is indicated for patients who have progressed on or are intolerant to crizotinib.
  • Phase III trials are evaluating ceritinib in first- and second-line settings.

Conclusions:

  • Ceritinib represents a significant advancement in the treatment of ALK-positive NSCLC.
  • The drug offers a crucial therapeutic option for patients with limited alternatives.
  • Ongoing research aims to further define ceritinib's role in NSCLC management.

More Related Videos

Kinase Inhibitor Screening In Self-assembled Human Protein Microarrays13:22

Kinase Inhibitor Screening In Self-assembled Human Protein Microarrays

Published on: October 23, 2019

8.5K
Drug-Induced Senescence in Liver Cells Promotes M2 Macrophage Polarization: Implications for Tyrosine Kinase Inhibitor-Associated Hepatotoxicity09:32

Drug-Induced Senescence in Liver Cells Promotes M2 Macrophage Polarization: Implications for Tyrosine Kinase Inhibitor-Associated Hepatotoxicity

Published on: October 17, 2025

660

Related Concept Videos

Treatment for Pulmonary Arterial Hypertension: Receptor Tyrosine Kinase Inhibitors and Calcium Channel Blockers01:26

Treatment for Pulmonary Arterial Hypertension: Receptor Tyrosine Kinase Inhibitors and Calcium Channel Blockers

Receptor tyrosine kinase inhibitors (TKIs) and calcium channel blockers (CCBs) are two critical categories of drugs employed in the treatment of pulmonary artery hypertension (PAH). PAH is a disease that causes high blood pressure in the pulmonary arteries, resulting in chest pain, fatigue, and shortness of breath.
TKIs, such as imatinib (Gleevec), are particularly effective in tackling the growth and mitogenic factors that become upregulated in PAH patients. These factors contribute to the...
688
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
341
PI3K/mTOR/AKT Signaling Pathway01:22

PI3K/mTOR/AKT Signaling Pathway

The mammalian target of rapamycin  (mTOR) is a serine/threonine kinase that regulates growth, proliferation, and cell survival in response to hormones, growth factors, or nutrient availability. This kinase exists in two structurally and functionally distinct forms: mTOR complex 1  (mTORC1) and mTOR complex 2  (mTORC2). The first form (mTORC1) is composed of a rapamycin-sensitive Raptor and proline-rich Akt substrate, PRAS40. In contrast,  mTORC2 consists of a...
5.1K
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against...
7.0K
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

1.4K
Treatment Resistent Cancers02:56

Treatment Resistent Cancers

1.1K