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Savolitinib: First Approval

Anthony Markham1

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

Drugs
|August 29, 2021
PubMed

Insights

Savolitinib is a new targeted therapy for non-small cell lung cancer (NSCLC) with specific genetic alterations. It has received conditional approval in China for patients who have not responded to chemotherapy.

Area of Science:

  • Oncology
  • Pharmacology
  • Medical Genetics

Background:

  • Savolitinib is a potent and selective inhibitor of the mesenchymal epithelial transition factor (MET) receptor tyrosine kinase.
  • MET alterations, including exon 14-skipping, are implicated in the development and progression of various cancers, notably non-small cell lung cancer (NSCLC).
  • Targeted therapies inhibiting MET offer a promising treatment strategy for NSCLC patients with specific genetic profiles.

Purpose of the Study:

  • To summarize the key milestones in the development of savolitinib.
  • To highlight the pivotal clinical trial data supporting its efficacy.
  • To document the regulatory approval process and its implications for NSCLC treatment.

Main Methods:

  • Review of preclinical data and early-phase clinical trials.
  • Analysis of results from a pivotal phase II trial in NSCLC patients with MET exon 14-skipping alterations.
  • Summary of the regulatory submission and approval pathway.

Main Results:

  • Savolitinib demonstrated significant clinical activity in a pivotal phase II trial.
  • The drug received conditional approval in China for metastatic NSCLC with MET exon 14-skipping alterations.
  • Approval is contingent upon further phase III trial results.

Conclusions:

  • Savolitinib represents a significant advancement in targeted therapy for a subset of NSCLC patients.
  • The drug's development highlights the importance of identifying specific genetic alterations for personalized cancer treatment.
  • Conditional approval in China marks a crucial step towards broader clinical accessibility.

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