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New FDA approval for ROZLYTREK™

Genentech is excited to share the news of a new FDA approval. ROZLYTREK™ (entrectinib) is now FDA approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.

ROZLYTREK is also FDA approved for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:

  • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,
  • are metastatic or where surgical resection is likely to result in severe morbidity, and 
  • have either progressed following treatment or have no satisfactory alternative therapy. 

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Please see the ROZLYTREK Day 1 Letter, as well as the full Prescribing Information, for additional Important Safety Information. This announcement includes patient assistance information, dosing, information regarding billing, coding, and distribution. Please forward to relevant stakeholders or departments in your organization.

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