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FDA Approval Summary: TAS-102.

Leigh Marcus1, Steven J Lemery2, Sachia Khasar2

  • 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak, Maryland. leigh.marcus@fda.hhs.gov.

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Summary
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The FDA-approved drug TAS-102 (Lonsurf) significantly improves overall survival and progression-free survival in patients with previously treated metastatic colorectal cancer (mCRC). This oral medication offers a new treatment option for advanced disease refractory to standard therapies.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Metastatic colorectal cancer (mCRC) presents a significant challenge, especially in patients refractory to standard chemotherapies, anti-VEGF, and anti-EGFR therapies.
  • Limited treatment options exist for patients with previously treated mCRC who have progressed on standard treatment regimens.
  • TAS-102 (Lonsurf) is an oral nucleoside analog approved by the FDA for specific mCRC patient populations.

Purpose of the Study:

  • To evaluate the efficacy and safety of TAS-102 compared to placebo in patients with previously treated metastatic colorectal cancer (mCRC).
  • To assess the impact of TAS-102 on overall survival (OS) and progression-free survival (PFS) in this patient population.

Main Methods:

  • An international, multicenter, double-blinded, placebo-controlled trial (RECOURSE) involving 800 patients with previously treated mCRC.
  • Patients were randomly assigned (2:1) to receive either TAS-102 (35 mg/m² orally twice daily) or a matching placebo over 28-day cycles.
  • Primary endpoints included overall survival and progression-free survival, with safety assessments of adverse reactions.

Main Results:

  • TAS-102 demonstrated a statistically significant improvement in median overall survival (7.1 months vs. 5.3 months; HR, 0.68; P < 0.001).
  • Progression-free survival was also significantly prolonged in the TAS-102 arm (HR, 0.47; P < 0.001).
  • The most common adverse reactions included anemia, neutropenia, fatigue, nausea, and thrombocytopenia; dose reduction was required in 13.7% of patients.

Conclusions:

  • TAS-102 significantly improves overall survival and progression-free survival in patients with previously treated metastatic colorectal cancer.
  • TAS-102 represents a valuable therapeutic option for patients with mCRC who have exhausted standard treatment options.
  • The safety profile of TAS-102 is manageable, with dose modifications often required due to adverse events like neutropenia and anemia.