(Solid Tumors, Lung Cancer) What Is the Recommended Dose of Rozlytrek (Entrectinib)?

FDA Approves Rozlytrek for NTRK Fusion-Positive Tumors and ROS1-Positive NSCLC

• September 21, 2019
• Reading time: 2 minutes

On August 16, 2019, the US Food and Drug Administration (FDA) approved Rozlytrek (entrectinib) for:

• Adult and pediatric patients with solid tumors harboring NTRK gene fusions that are metastatic, where surgical resection would likely result in severe morbidity, or that have progressed following treatment, or when no satisfactory alternative treatment exists
• Patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC)

NTRK-Positive Solid Tumors

Efficacy was validated in three multicenter, single-arm clinical trials: the ALKA trial, STARTRK-1 trial, and STARTRK-2 trial. Various doses and treatment schedules of Rozlytrek were evaluated in 54 adult patients, of whom 94% received oral Rozlytrek 600 mg once daily. Prior to enrollment, NTRK fusion gene positivity was confirmed by nucleic acid testing at each institution or a central laboratory.

Results (independent review):

• Response rate in 54 adult patients: 57%
• Duration of response:
  • ≥6 months: 68% of patients
  • ≥12 months: 45% of patients
• Cancer types: Sarcoma, NSCLC, secretory breast analogue carcinoma, breast cancer, thyroid cancer, colorectal cancer, and others

ROS1-Positive Metastatic NSCLC

Efficacy was validated in three clinical trials with various doses and schedules in 51 adult patients. 90% received oral Rozlytrek 600 mg once daily.

• Response rate: 78%
• Duration of response: 55% of patients had responses lasting ≥12 months

Safety Profile

Serious adverse events: congestive heart failure, CNS effects, fractures, hepatotoxicity, hyperuricemia, QT prolongation, and vision impairment.

Common adverse events (≥20%): fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, paresthesia, dyspnea, myalgia, cognitive impairment, weight gain, cough, vomiting, fever, arthralgia, visual disturbance.

Recommended Dose

For NTRK fusion-positive solid tumors and ROS1-positive metastatic NSCLC: Rozlytrek 600 mg orally once daily.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-entrectinib-ntrk-solid-tumors-and-ros-1-nsclc

Tags: #SolidTumors #LungCancer

• Clinical trial drug

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