For adult and paediatric patients with NTRK gene fusion-positive solid tumours1
VITRAKVI▼ (larotrectinib) A FIRST-IN-CLASS SELECTIVE TRK INHIBITOR FOR TRK FUSION CANCER ACROSS SOLID TUMORS1,2
Efficacy demonstrated in different solid tumours with NTRK fusion¹
Low rate of AEs in adult and paediatric patients¹
Twice
daily oral
dosing¹
VITRAKVI▼ is a ‘histology independent’ (or ‘tumour agnostic’) treatment that can be used in a variety of solid tumours driven by neurotrophic tyrosine receptor kinase (NTRK) fusions in both adult and paediatric patients.1
VITRAKVI is recommended for the treatment of adult and paediatric patients with solid tumours that display a NTRK gene fusion:1,2
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who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity
-
and who have no satisfactory treatment options.
Treatment with VITRAKVI should be initiated by physicians experienced in the administration of anticancer therapies. The presence of an NTRK gene fusion in a tumour specimen should be confirmed by a validated test prior to initiation of treatment with VITRAKVI.1
To learn more about testing for NTRK fusions, click here.
The benefit of VITRAKVI was evaluated in the largest population of patients with NTRK gene fusion cancer to date1,3-6
The efficacy and safety profile of VITRAKVI was studied in three multicentre, open-label, single-arm clinical studies in adult and paediatric cancer patients with a wide range of tumour types.1 The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as determined by a blinded independent review committee (BIRC).1
First 55 consecutively enrolled adult and paediatric patients*
on which approval of VITRAKVI was based 1,3
225 patients in the pooled efficacy population,* including:1
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192 patients with non-CNS primary tumours (pooled primary analysis set)
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33 patients with primary CNS tumours (post hoc addition)
248 patients in the safety population†1
Some eligibility criteria differed between these studies.
* Patients with NTRK fusion-positive cancer.
† The safety population was larger because it included all patients from the three studies who received at least one dose of VITRAKVI and was not limited to patients with tumours harbouring NTRK gene fusion.
VITRAKVI is a selective TRK inhibitor, designed to treat TRK fusion cancer regardless of where it starts1,2
VITRAKVI has demonstrated selective inhibition of TRK proteins (TRKA, TRKB, and TRKC):1
• In vitro IC₅₀ values between 5 and 11 nM (specificity is 100x greater for TRK than for other kinases)1
VITRAKVI blocks the TRK downstream signalling pathways, resulting in inhibition of tumour growth1,6
MAPK, mitogen activated protein kinase; PI3K, phosphatidylinositol-4,5-bisphosphate 3-kinase; PLCγ, phospholipase C-γ; TRK, tropomyosin receptor kinase.
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Reporting adverse events and quality complaints
Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigiliance. Reports can also be sent directly to Bayer via this link. Both side effects or quality complaints can be reported to Bayer by email to adr-ireland@bayerhealthcare.com
