Safety profile demonstrated in 355 patients across 4 trials 1

  • Safety was evaluated in 355 patients, including 17 pediatric patients (<18 years of age) 1,4
    • 48% of patients were treated with ROZLYTREK for 6 months or longer and 24% of patients were treated for 1 year or longer
  • Serious adverse reactions occurred in 39% of patients
    • The most frequent serious adverse reactions (≥2%) were pneumonia (3.9%), dyspnea (3.7%), pleural effusion (3.4%), sepsis (2.5%), pulmonary embolism (2.3%), respiratory failure (2%), and pyrexia (2%)
  • Fatal events included dyspnea (0.6%), pneumonia (0.6%), sepsis (0.6%), completed suicide (0.3%), large intestine perforation (0.3%), and tumor lysis syndrome (0.3%)
    • 1 patient developed Grade 4 myocarditis after 1 dose of ROZLYTREK, which resolved after discontinuation of ROZLYTREK and administration of high-dose corticosteroids
  • Dose reductions due to adverse reactions occurred in 29% of patients
  • Permanent discontinuation of ROZLYTREK for adverse reactions occurred in 9% of patients
    • The most frequent adverse reactions that led to permanent discontinuation of ROZLYTREK were pneumonia, cardio-respiratory arrest, dyspnea, and fatigue

Most common adverse reactions (≥10%) in patients treated with ROZLYTREK in studies ALKA, STARTRK-1, STARTRK-2, and STARTRK-NG

aGrades 3-5, inclusive of fatal adverse reactions, including 2 events of pneumonia and 2 events of dyspnea.
bIncludes fatigue, asthenia.
cIncludes face edema, fluid retention, generalized edema, localized edema, edema, edema peripheral, peripheral swelling.
dIncludes abdominal pain upper, abdominal pain, lower abdominal discomfort, abdominal tenderness.
eIncludes dizziness, vertigo, dizziness postural.
fIncludes paresthesia, hyperesthesia, hypoesthesia, dysesthesia, oral hypoaesthesia, palmar-plantar erythrodysaesthesia, oral paresthesia, genital hypoaesthesia.
gIncludes amnesia, aphasia, cognitive disorder, confusional state, delirium, disturbance in attention, hallucinations, visual hallucination, memory impairment, mental disorder, mental status changes.
hIncludes neuralgia, neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy.
iIncludes ataxia, balance disorder, gait disturbances.
jIncludes hypersomnia, insomnia, sleep disorder, somnolence.
kIncludes anxiety, affect lability, affective disorder, agitation, depressed mood, euphoric mood, mood altered, mood swings, irritability, depression, persistent depressive disorder, psychomotor retardation.
lIncludes musculoskeletal pain, musculoskeletal chest pain, myalgia, neck pain.
mIncludes blindness, cataract, cortical cataract, corneal erosion, diplopia, eye disorder, photophobia, photopsia, retinal hemorrhage, vision blurred, visual impairment, vitreous adhesions, vitreous detachment, vitreous floaters.
nIncludes lower respiratory tract infection, lung infection, pneumonia, respiratory tract infection.
oIncludes hypotension, orthostatic hypotension.
pIncludes rash, rash maculopapular, rash pruritic, rash erythematous, rash papular.

Laboratory abnormalities 1

Laboratory abnormalities (≥20%) worsening from baseline in patients receiving ROZLYTREK in ALKA, STARTRK-1, STARTRK-2, and STARTRK-NG

qDenominator for each laboratory parameter is based on the number of patients with a baseline and post-treatment laboratory value available, which ranged from 111 to 346 patients.
rBased on NCI-CTCAE v5.0.
sNE=not evaluable. Grade 1 and 2 could not be determined per NCI-CTCAE v5.0, as fasting glucose values were not collected.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; NCI-CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

Ongoing monitoring considerations with ROZLYTREK 1

This list reflects a subset of monitoring considerations. For additional important considerations, please see the full Prescribing Information.

ROS1+ Study Design

ROS1+ mNSCLC Study Design

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ROZLYTREK Efficacy in ROS1+ Patients

Efficacy in ROS1+ mNSCLC Patients

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ROZLYTREK Financial Resources

Financial and Other Resources

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