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Labeling Stem Cells with Ferumoxytol, an FDA-Approved Iron Oxide Nanoparticle
Published on: November 4, 2011
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Lorlatinib: First Global Approval.
1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.
Drugs
|January 4, 2019
Summary
Lorlatinib, an ALK and ROS1 inhibitor, is approved for ALK-positive non-small cell lung cancer. This summary outlines its development milestones leading to global regulatory approval.
Area of Science:
- Oncology
- Pharmacology
- Drug Development
Background:
- Anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (ROS1) kinase alterations drive certain non-small cell lung cancers (NSCLC).
- Targeted therapies inhibiting ALK and ROS1 have improved outcomes for patients with advanced NSCLC.
- Lorlatinib represents a next-generation inhibitor designed to overcome resistance mechanisms.
Purpose of the Study:
- To summarize the key development milestones of lorlatinib.
- To highlight the clinical trial data supporting its efficacy and safety.
- To document the regulatory pathway leading to its first global approval.
Main Methods:
- Review of preclinical data and early-phase clinical trials (Phase I/II).
- Analysis of efficacy and safety endpoints from pivotal studies.
- Examination of the regulatory submission and approval process.
Main Results:
- Lorlatinib demonstrated significant activity in patients with ALK-positive NSCLC.
- Phase I/II trial results formed the basis for regulatory submissions.
- Successful approvals were obtained in Japan (September 2018) and the USA (November 2018).
Conclusions:
- Lorlatinib's development signifies a crucial advancement in targeted therapy for ALK-positive NSCLC.
- The drug's approval offers a new treatment option for patients with this specific genetic profile.
- This summary provides a historical overview of lorlatinib's journey to market.
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