Chugai Obtains Approval for Additional Indication of Rozlytrek for?ROS1?Fusion-Positive Non-Small Cell Lung Cancer
- Rozlytrek approved for?ROS1?fusion-positive non-small cell lung cancer following MHLW approval of Rozlytrek for?NTRK?fusion-positive solid tumors last year
- ROS1?fusion gene is found in 1 to 2% of patients with non-small cell lung cancer and is one of the important cancer-driver genes in the treatment of lung cancer
TOKYO, February 21, 2020 --?Chugai Pharmaceutical Co., Ltd.?(TOKYO: 4519) announced today that it obtained approval for an additional indication of an anticancer agent/tyrosine kinase inhibitor, Rozlytrek??(generic name: entrectinib) for the treatment of?ROS1?fusion-positive, unresectable, advanced or metastatic non-small cell lung cancer (NSCLC) from the Ministry of Health, Labour and Welfare (MHLW).
?We are very pleased to announce the approval of Rozlytrek for the treatment in adults with?ROS1?fusion-positive NSCLC. Rozlytrek was launched last year as Chugai?s first product to embody advanced personalized healthcare for the treatment of patients with?NTRK?fusion-positive solid tumors regardless of their age or site of origin,? said Dr. Osamu Okuda, Executive Vice President, Co-Head of Project & Lifecycle Management Unit. ?ROS1?is an important cancer-driver gene found in 1 to 2% of patients with NSCLC. Offering Rozlytrek as a new treatment option for?ROS1fusion-positive NSCLC patients, we will continue making efforts to contribute to the progress in advanced personalized medicine.?
This approval is based mainly on the results of an open-label, multicenter, global phase II STARTRK-2 study. Efficacy was evaluated in?ROS1?fusion-positive NSCLC cohort from the STARTRK-2 study while safety was evaluated in two overseas phase I studies (STARTRK-1 study and ALKA-372-001 study) in addition to STARTRK-2 study.
FoundationOne CDx??Cancer Genomic Profile is used as a companion diagnostic to identify people that could potentially benefit from Rozlyterk for the?ROS1?fusion-positive, unresectable, advanced or metastatic NSCLC. The MHLW granted the approval for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic of Rozlytrek on December 25, 2019.
As a leading company in the field of oncology, Chugai is committed to contribute to patients and medical professionals through realization of advanced personalized healthcare.
[Reference information]
Chugai Obtains Approval for Expanded Use of FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Rozlytrek for?ROS1-positive Lung Cancer (A press release issued by Chugai on December 26, 2019)
https://www.chugai-pharm.co.jp/english/news/detail/20191226113000_678.html
Roche?s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer (A press release issued by Roche on September 24, 2018)
https://www.roche.com/media/releases/med-cor-2018-09-24c.htm
Approval information?The underlined part has been newly added.
Product name | Rozlytrek??Capsules 100 mg Rozlytrek??Capsules 200 mg |
Generic name | entrectinib |
Indications | NTRK?fusion-positive advanced or metastatic solid tumors ROS1?fusion gene positive, unresectable, advanced or metastatic non-small cell lung cancer |
Dosage and administration |
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Conditions for approval |
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[Reference]
- Bergethon K, Shaw AT, Ou SH, et al.?ROS1?rearrangements define a unique molecular class of lung cancers. J Clin Oncol 2012;30:863-70.