VYSIS ALK BREAK APART FISH lets the patient’s signal guide the need for ALK-directed therapy
ALK test results provide a clear positive or negative result. The test identifies ALK gene rearrangements in NSCLC patients so that the oncologist can determine which patients can potentially benefit from the ALK-directed therapeutic drug XALKORI®.
XALKORI® clinical trial information, Phase 21
- 136 patients with locally advanced or metastatic ALK-positive NSCLC were treated with single-agent XALKORI® in a multi-center, single-arm study.
- ALK-positive NSCLC was identified using the Vysis ALK Break Apart FISH Probe Kit.
- Patients received 250 mg of XALKORI® orally twice daily.
- Primary endpoint: Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
- Median duration of treatment: 22 weeks.
- Results: 1 complete and 67 partial responses for an ORR of 50% (95% CI: 42%, 59%). 79% of objective tumor responses were achieved during the first 8 weeks of treatment.
Patients in this clinical trial were all ALK-positive and treated with XALKORI®, regardless of the phenotypic characteristics of sex, age, race, smoking status, or the histological classification of their NSCLC.
Vysis ALK is the first molecular diagnostic test approved by the FDA to aid in identifying the ALK status of patients with NSCLC.
1. Vysis ALK Break Apart FISH Probes Kit Package Insert 30-608495