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Lorlatinib: First Global Approval

Yahiya Y Syed1

  • 1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.

Drugs
|January 4, 2019
PubMed

Insights

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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