Chugai Receives MHLW’s Approval for the Expanded Use of FoundationOne CDx as a Companion Diagnostic of Rozlytrek (entrectinib)

 Chugai Receives MHLW’s Approval for the Expanded Use of FoundationOne CDx as a Companion Diagnostic of Rozlytrek (entrectinib)

Chugai Receives MHLW’s Approval for the Expanded Use of FoundationOne CDx as a Companion Diagnostic of Rozlytrek (entrectinib)

Shots:

  • The MHLW has approved the expanded use of FoundationOne CDx for Rozlytrek to treat ROS1 fusion-positive, LA/ m-NSCLC, allowing the physician to identify NSCLC patients who could benefit from Rozlytrek by detecting ROS1 fusion genes
  • On Mar 15, 2019, Chugai has filed an application for the additional indication of Rozlytrek. Chugai will further expand the CDx functions of FoundationOne CDx for its in-house therapies and in collaboration with other biopharma partners
  • Rozlytrek is an oral tyrosine kinase inhibitor targeting ROS1 and TRK kinase activity, thus inhibiting the proliferation of cancer cells with ROS1 or NTRK gene fusions. FoundationOne CDx is a sequencing-based in vitro diagnostic device that detects mutations in 324 genes, select gene rearrangements and genomic signatures including MSI & TMB

Click here to­ read full press release/ article | Ref: Chugai Pharmaceutical  | Image:  Chugai Pharmaceutical