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 ROS1 fusion-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 In case of patients with NTRK fusion-positive advanced or metastatic solid tumors. The usual adult dosage is 600 mg entrectinib administered orally once a day. Reduce the dose as necessary depending on the patient’s condition. The usual pediatric dosage is 300 mg/m 2 (body surface area) entrectinib administered orally once a day. However, the dose should not exceed 600 mg. Reduce the dose as necessary depending on the patient’s condition. In case of patients with ROS1 fusion gene positive, unresectable, advanced or metastatic non-small cell lung cancer. The usual adult dosage is 600 mg entrectinib administered orally once a day. Reduce the dose as necessary depending on the patient’s condition. Conditions for approval A risk management plan should be created and appropriately implemented. Given that the number of patients in clinical studies in Japan was extremely limited, post-marketing drug use surveillance of all patients receiving Rozlytrek should be conducted until data for a certain number of patients have been accumulated, in order to understand background information on patients receiving Rozlytrek, collect early data on the safety and efficacy of Rozlytrek, and take necessary measures for appropriate use of Rozlytrek. About Rozlytrek Rozlytrek is an oral tyrosine kinase inhibitor that blocks ROS1 (c-ros oncogene 1) and TRK (neurotrophin receptors) family strongly and selectively. It blocks ROS1 and TRK kinase activity, and inhibits proliferation of cancer cells with ROS1 or NTRK gene fusions. Rozlytrek was approved for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 gene fusions on June 18, 2019 and was launched on September 4, 2019. About ROS1 fusion-positive NSCLC ROS1 fusion gene is an abnormal gene that can be formed by fusing the ROS1 gene and other genes ( CD74 , etc.) as a result of chromosomal translocation for some reason. The ROS1 fusion kinase made from ROS1 fusion gene is thought to promote cancer cell proliferation. ROS1 fusion gene is found in about 1 to 2% of NSCLC, among which it is more expressed in adenocarcinoma. 1) Trademarks used or mentioned in this release are protected by law. [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.

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