- MHLW approved FoundationOne CDx as a companion diagnostic for Alecensa (alectinib) to detect ALK fusion gene–positive solid tumors on March 9, 2026.
- Chugai obtained a partial change to Alecensa's marketing authorization on May 18, 2026 based on the investigator‑initiated Japanese Phase II TACKLE study assessing efficacy and safety in advanced or recurrent ALK fusion gene‑positive solid tumors.
- FoundationOne CDx is an NGS‑based in vitro diagnostic that detects substitutions, indels, copy number alterations and select rearrangements across 324 genes, plus MSI and TMB, from FFPE tumor tissue.
- The approval expands FoundationOne CDx's tumor‑agnostic companion‑diagnostic scope beyond NSCLC, broadening potential treatment options for ALK fusion gene‑positive solid tumors.
Regulatory approval
MHLW approved on March 9, 2026 FoundationOne CDx as a companion diagnostic for Alecensa (alectinib) to detect ALK fusion gene–positive solid tumors, enabling treatment decisions for Alecensa based on the test.
Clinical basis
Efficacy and safety of Alecensa in advanced or recurrent ALK fusion gene–positive solid tumors were evaluated in an investigator‑initiated Japanese Phase II TACKLE study; a partial change to Alecensa's marketing authorization was granted on May 18, 2026.
Test capabilities
FoundationOne CDx is an NGS‑based in vitro diagnostic that detects substitutions, insertions/deletions, copy‑number alterations and select rearrangements across 324 genes and reports microsatellite instability and tumor mutational burden from FFPE tumor tissue.
Implication
The approval extends the test's tumor‑agnostic companion‑diagnostic scope beyond non‑small cell lung cancer, broadening actionable genomic profiling options for patients with ALK fusion gene–positive solid tumors.
