• Confidence Interval (CI) calculated using the Clopper-Pearson method

ROZLYTREK: Observed duration of response 1

c+ denotes ongoing response.
dResponse duration was based on additional 5 months’ follow-up after primary analysis of ORR.1 Median duration of follow-up from the time of first response was 19.8 months at time of data cutoff (October 31, 2018). 4
N=size of efficacy-evaluable population; n=number of responders.
CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response.

Congestive Heart Failure

  • Congestive heart failure (CHF) occurred in 12 patients (3.4%), including Grade 3 (2.3%). The median time to onset was 2 months (range: 11 days to 12 months). Of these 12 patients, ROZLYTREK was interrupted in 6 (50%) and discontinued in 2 (17%). CHF resolved in 6 patients (50%) following interruption or discontinuation of ROZLYTREK and institution of appropriate medical management. In addition, myocarditis in the absence of CHF was documented in 0.3% of patients.

ROZLYTREK demonstrated responses in the CNS 1

  • Among the 51 patients, 7 had measurable CNS metastases at baseline and had not received radiation therapy to the brain within 2 months prior to study entry
  • Intracranial response according to RECIST v1.1 was assessed by BICR

BICR=Blinded Independent Central Review; CNS=central nervous system.

Congestive Heart Failure

  • Assess left ventricular ejection fraction (LVEF) prior to initiation of ROZLYTREK in patients with symptoms or known risk factors for CHF. Monitor patients for clinical signs and symptoms of CHF, including shortness of breath and edema. For patients with myocarditis, with or without a decreased ejection fraction, MRI or cardiac biopsy may be required to make the diagnosis. For patients with new onset or worsening CHF, withhold ROZLYTREK, institute appropriate medical management, and reassess LVEF. Based on the severity of CHF or worsening LVEF, resume ROZLYTREK at a reduced dose upon recovery to baseline or permanently discontinue.

Efficacy was studied in ROS1 inhibitor-naïve patients with ROS1+ mNSCLC 1

eORR, DOR, and intracranial response were measured according to RECIST v1.1 and evaluated by BICR.
BICR=Blinded Independent Central Review; CNS=central nervous system; DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; FISH=fluorescence in situ hybridization; mNSCLC=metastatic non-small cell lung cancer; NGS=next generation sequencing; ORR=objective response rate; PS=performance status; ROS1=ROS proto-oncogene 1.

Entrectinib (ROZLYTREK) is a Category 2A (preferred) option for first-line treatment of patients with ROS1 rearrangement positive metastatic NSCLC in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) 3a,b

aWhen a ROS1 rearrangement is discovered prior to, or during, first-line systemic therapy.
bThe National Comprehensive Cancer Network® (NCCN) makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

ROZLYTREK Dosing and Administration

Dosing and Administration

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ROZLYTREK Safety Profile

Safety Profile

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ROZLYTREK Financial resources

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