Rozlytrek (entrectinib) is a targeted therapy that has been approved by the FDA for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) and certain NTRK fusion-positive solid tumors. It is an orally administered, non-chemotherapeutic treatment designed to inhibit the activity of abnormal TRK fusion proteins identified in these specific cancers. Available in capsule form with strengths of 100 mg and 200 mg.

ROS1-Positive Non-Small Cell Lung Cancer

Rozlytrek is indicated for the treatment of adult patients with ROS1-positive metastatic NSCLC, as detected by an FDA-approved test. ROS1 rearrangements occur in 1-2% of NSCLC diagnoses, leading to the uncontrolled growth and proliferation of cancer cells. Rozlytrek targets these abnormal TRK fusion proteins, inhibiting their activity and limiting the growth of cancer cells.

NTRK Gene Fusion-Positive Solid Tumors

Rozlytrek is also indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have NTRK gene fusions. NTRK gene fusions occur when NTRK1/2/3 genes fuse with other genes, leading to the formation of abnormal TRK fusion proteins. Rozlytrek targets these abnormal TRK fusion proteins, inhibiting their activity and limiting the growth of cancer cells.

Safety And Side Effects

The most common adverse reactions in patients receiving Rozlytrek include fatigue, nausea, diarrhea, constipation, and headache. Rozlytrek has a manageable safety profile, and patients should be monitored for potential side effects.

Clinical Trial of Rozlytrek

Rozlytrek has exhibited notable efficacy in clinical studies, demonstrating favorable outcomes in tumor size reduction and maintaining a well-tolerated safety profile. Its utility is particularly advantageous for patients with solid tumors featuring NTRK gene fusion, providing a valuable treatment option in situations where alternative therapies are unavailable or ineffective.

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Reference:

  1.  https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212725s000lbl.pdf
  2. https://www.Rozlytrek.com 
  3.  https://www.Rozlytrek-hcp.com 
  4.  https://www.Rozlytrek.com/ntrk.html 
  5. https://www.Rozlytrek.com/ntrk/what-are-ntrk-fusion-positive-solid-tumors/treatment.html