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PATIENT CASES

VITRAKVI®: EXPLORE DISTINCT ADULT AND PEDIATRIC PATIENT CASES ACROSS SOLID TUMORS1-5

Each individual case reports a response from 1 patient. Different patients have different responses to therapy. To see efficacy by solid tumor type from our Initial Data Set, click here.

 

Explore the treatment journey of actual VITRAKVI patients. Each case provides an overview inclusive of the patient’s clinical presentation, previous treatments, molecular testing profile, VITRAKVI treatment regimen, and disease resolution.

 

Click below to choose a patient case by disease profile.

Icon of human lungs
NSCLCa PATIENTS WITH METASTATIC DISEASE
Lung cancer scan in primary and metastatic lesions for a 76-year-old female patient

BASELINE

Lung cancer scan in primary and metastatic lesions for a 76-year-old female patient

MONTH 4 OF TREATMENT

76-YEAR-OLD FEMALE WITH BRAIN METASTASES1

Pre- and post-treatment imaging, by Rosen EY et al, is licensed under Creative Commons License CC BY 4.0.

Scan of lungs and bones in primary and metastatic lesions from a Metastatic NSCLC for a 30-year-old female patient

INITIAL DIAGNOSIS

Scan of lungs and bones in primary and metastatic lesions from a Metastatic NSCLC for a 30-year-old female patient

6 WEEKS AFTER TREATMENT

30-YEAR-OLD FEMALE WITH BONE METASTASES2

Images courtesy of Dr Maximilian Hochmair.

Icon of human thyroid gland
THYROID CANCER PATIENTS WITH METASTATIC DISEASE
Female thyroid cancer patient body scan in primary and metastatic lesions in a 2-month treatment duration

BASELINE

Female thyroid cancer patient body scan in primary and metastatic lesions in a 2-month treatment duration

AFTER 2 MONTHS OF TREATMENT

56-YEAR-OLD FEMALE WITH MULTIPLE METASTASES3

Images courtesy of Dr Fabian Pitoia.

Scan of primary and metastatic lesions from a Metastatic disease for a 30-year-old male patient

BASELINE

Scan of primary and metastatic lesions from a Metastatic disease for a 30-year-old male patient

AFTER 31 MONTHS

33-YEAR-OLD MALE4

 

Images courtesy of Dr Steven Waguespack.

Icon of children, a boy and girl
PEDIATRIC CANCER PATIENT WITH METASTATIC DISEASE
Tumor scan showing reduction in tumor in a 5-month-old with infantile fibrosarcoma

BASELINE BEFORE VITRAKVI

Tumor scan showing reduction in tumor in a 5-month-old with infantile fibrosarcoma

AFTER 6 MONTHS ON VITRAKVI

5-MONTH-OLD WITH INFANTILE FIBROSARCOMA5

Pre- and post-treatment imaging, by Rosen EY et al, is licensed under Creative Commons License CC BY 4.0.

aNSCLC, non-small cell lung cancer; NTRK, neurotrophic receptor tyrosine kinase.

VITRAKVI is approved under accelerated approval based on overall response rate and duration of response. Continued approval for VITRAKVI may be contingent upon verification and description of clinical benefit in confirmatory trials.6

View Guidelines

References

  • Rosen EY, Schram AM, Young RJ, et al. Larotrectinib demonstrates CNS efficacy in TRK fusion-positive solid tumors. JCO Precis Oncol. 2019;3:1-5. Return to content
  • Blay J-Y, Brose MS, García-Foncillas J, Hochmair MJ, Vainer G. Precision medicine in real-world clinical practice: perspectives from a multidisciplinary team. Virtual presentation at: European Society for Medical Oncology Virtual Congress 2020 Industry Satellite Symposium. On demand from September 14, 2020. Return to content
  • Pitoia F. Complete response to larotrectinib treatment in a patient with papillary thyroid cancer harboring an ETV6-NTRK3 gene fusion. Clin Case Rep. 2021;9(4):1905-1912. Return to content
  • Waguespack SG, Drilon A, Farago AF, et al. Treatment of advanced TRK fusion thyroid cancer with larotrectinib. Presented at: 42nd Annual Meeting of the European Thyroid Association; September 7-10, 2019; Budapest, Hungary. Return to content
  • DuBois SG, Laetsch TW, Federman N, et al. The use of neoadjuvant larotrectinib in the management of children with locally advanced TRK fusion sarcomas. Cancer. 2018;124(21):4241-4247. Return to content
  • VITRAKVI [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; November 2023. Return to content
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Indication

VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that:

  • have a neurotrophic receptor tyrosine 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 no satisfactory alternative treatments or that have progressed following treatment.

Select patients for therapy based on an FDA-approved test.

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

Important Safety Information

Warning and Precautions

  • Central Nervous System Effects: Central nervous system (CNS) adverse reactions occurred in patients receiving VITRAKVI, including dizziness, cognitive impairment, mood disorders, and sleep disturbances.

    In patients who received VITRAKVI, all grades CNS effects including cognitive impairment, mood disorders, dizziness and sleep disorders were observed in 42% with Grades 3-4 in 3.9% of patients.

    Cognitive impairment occurred in 11% of patients. The median time to onset of cognitive impairment was 5.6 months (range: 2 days to 41 months). Cognitive impairment occurring in ≥1% of patients included memory impairment (3.6%), confusional state (2.9%), disturbance in attention (2.9%), delirium (2.2%), cognitive disorders (1.4%), and Grade 3 cognitive adverse reactions occurred in 2.5% of patients. Among the 30 patients with cognitive impairment, 7% required a dose modification and 20% required dose interruption.

    Mood disorders occurred in 14% of patients. The median time to onset of mood disorders was 3.9 months (range: 1 day to 40.5 months). Mood disorders occurring in ≥1% of patients included anxiety (5%), depression (3.9%), agitation (2.9%), and irritability (2.9%). Grade 3 mood disorders occurred in 0.4% of patients.

    Dizziness occurred in 27% of patients, and Grade 3 dizziness occurred in 1.1% of patients. Among the 74 patients who experienced dizziness, 5% of patients required a dose modification and 5% required dose interruption.

    Sleep disturbances occurred in 10% of patients. Sleep disturbances included insomnia (7%), somnolence (2.5%), and sleep disorder (0.4%). There were no Grade 3-4 sleep disturbances. Among the 28 patients who experienced sleep disturbances, 1 patient each (3.6%) required a dose modification or dose interruption.

    Advise patients and caretakers of these risks with VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed.

  • Skeletal Fractures: Among 187 adult patients who received VITRAKVI across clinical trials, fractures were reported in 7% and among 92 pediatric patients, fractures were reported in 9% (N=279; 8%). Median time to fracture was 11.6 months (range 0.9 to 45.8 months) in patients followed per fracture. Fractures of the femur, hip or acetabulum were reported in 4 patients (3 adult, 1 pediatric). Most fractures were associated with minimal or moderate trauma. Some fractures were associated with radiologic abnormalities suggestive of local tumor involvement. VITRAKVI treatment was interrupted due to fracture in 1.4% patients.

    Promptly evaluate patients with signs or symptoms of potential fracture (e.g., pain, changes in mobility, deformity). There are no data on the effects of VITRAKVI on healing of known fractures or risk of future fractures.

  • Hepatotoxicity: Hepatotoxicity including drug induced liver injury (DILI) has been reported in patients taking VITRAKVI.

    In patients who received VITRAKVI, increased AST of any grade occurred in 52% of patients and increased ALT of any grade occurred in 45%. Grade 3-4 increased AST or ALT occurred in 3.1% and 2.5% of patients, respectively. The median time to onset of increased AST was 2.1 months (range: 1 day to 4.3 years). The median time to onset of increased ALT was 2.3 months (range: 1 day to 4.2 years). Increased AST and ALT leading to dose modifications occurred in 1.4% and 2.2% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 3 (1.1%) of patients.

    There have been reports in adult patients from clinical studies and post-marketing cases of Grade ≥ 2 increases in ALT and/or AST with increases in bilirubin ≥ 2 x ULN.

    Obtain liver function tests (ALT, AST, ALP and bilirubin) before initiation of VITRAKVI and monitor every 2 weeks during the first two months of treatment, then monthly thereafter, or more frequently following the occurrence of Grade 2 or greater AST or ALT elevation. Temporarily withhold, reduce the dose, or permanently discontinue VITRAKVI based on severity.

  • Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman. Larotrectinib resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the final dose of VITRAKVI.

Adverse Reactions

  • The most common adverse reactions (≥20%), including laboratory abnormalities, were: increased AST (52%), increased ALT (45%), anemia (42%), musculoskeletal pain (42%), fatigue (36%), hypoalbuminemia (36%), neutropenia (36%), increased alkaline phosphatase (34%), cough (32%), leukopenia (28%), constipation (27%), diarrhea (27%), dizziness (27%), hypocalcemia (25%), nausea (25%), vomiting (25%), pyrexia (24%), lymphopenia (22%) and abdominal pain (21%).

Drug Interactions

  • Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors (including grapefruit or grapefruit juice), strong CYP3A4 inducers (including St. John’s wort), or sensitive CYP3A4 substrates. If coadministration of strong CYP3A4 inhibitors or inducers cannot be avoided, modify the VITRAKVI dose as recommended. If coadministration of sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs. For coadministration with moderate CYP3A4 inhibitors, monitor for adverse reactions more frequently and reduce the dosage based on severity. For coadministration with moderate CYP3A4 inducers, modify dose as recommended.

Use in Specific Populations

  • Lactation: Advise women not to breastfeed during treatment with VITRAKVI and for 1 week after the final dose.

For important risk and use information about VITRAKVI, please see the full Prescribing Information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

For Bayer products, you can report these directly to Bayer by clicking here.

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This site is intended for US audiences only.

Site last updated on 10/2024

© 2024 Bayer. All rights reserved. Bayer, the Bayer Cross, and VITRAKVI are registered trademarks of Bayer, and Access Services by Bayer is a trademark of Bayer. All other trademarks are the property of their respective owners.

 

This site is intended for US audiences only.

 

Site last updated on 10/2024