~Contributing to the development of new treatments~ First approval of nivolumab for malignant mesothelioma (non-pleural) based on results of investigator-initiated clinical trial (VIOLA study)

Hyogo Medical University Hospital (Nishinomiya City, Hyogo Prefecture, Director: Masafumi Sakagami) began a Phase II investigator-initiated clinical trial (VIOLA study) in October 2020 using the cancer immunotherapy drug Opdivo® (generic name: nivolumab) in patients with malignant mesothelioma (excluding malignant pleural mesothelioma).

<Reference: Hyogo College Hyogo Medical University News Release Page>
~ Aiming to develop new treatments ~ Investigator-initiated clinical trials for malignant mesothelioma (non-pleural) commenced
　https://www.hyo-med.ac.jp/corporation/publicity/news-releases/134/

The VIOLA study was led by Hyogo Medical University Hospital and was conducted by a total of five facilities, including our hospital, in 20 patients with nonpleural malignant mesothelioma (11 of whom were from Hyogo Medical University Hospital), regardless of whether they had a history of chemotherapy, with the aim of examining the efficacy and safety of Opdivo 240 mg administered every two weeks.

Based on the results of this trial, Ono Pharmaceutical Co., Ltd. submitted an application for approval to partially change the domestic manufacturing and marketing approval of Opdivo® Intravenous Infusion to add an indication or efficacy for malignant mesothelioma (excluding malignant pleural mesothelioma), and obtained the first approval in Japan for this indication on November 24, 2023.

<Reference: Ono Pharmaceutical Co., Ltd. News page>
Opdivo® Intravenous Infusion Approved for Partial Amendment to Domestic Marketing Approval for Additional Indication or Efficacy for Malignant Mesothelioma (Excluding Malignant Pleural Mesothelioma)
　https://www.ono-pharma.com/ja/news/20231124.html

Until now, there have been no drugs approved in Japan or overseas for the treatment of malignant mesothelioma other than malignant pleural mesothelioma, and no standard treatment has been established. With this approval, it is expected that Opdivo will become a new treatment option.