June 15, 2020
APROMISS trial amendment has been approved by the Italian Ethical Committee.
March 16, 2018
Advenchen is excited to announce the European Medicines Agency (EMA) granted AL3818 orphan designation for the treatment of soft tissue sarcomas on February 22, 2018. To qualify for orphan designation, a medicine must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that is prevalent in less than 5 in 10,000 people in the EU and must be of significant benefit to those affected by the condition. AL3818 is being evaluated for the treatment of alveolar soft part sarcoma, leiomyosarcoma, and synovial sarcoma in a global phase 3 trial. The trial is now open for recruitment at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy.
December 6, 2017
Advenchen is preparing for regulatory submission to open APROMISS (NCT03016819), the global phase 3 evaluation of AL3818 in soft tissue sarcoma, in Japan. The consultation meeting with the PMDA has been scheduled for the end of December 2017.
July 12, 2017
Advenchen is pleased to announce the FDA has granted AL3818 orphan drug designation for the potential treatment of soft tissue sarcomas. Soft tissue sarcomas are considered an orphan disease in the U.S. and there are still limited treatment options available. This is an exciting accomplishment supporting Advenchen’s efforts pursuing AL3818 in patients with alveolar soft part sarcoma, leiomyosarcoma, and synovial sarcoma. The FDA Orphan Drug Designation program grants orphan designation for drugs intended for diseases or conditions that affect fewer than 200,000 people in the United States.
January 11, 2017
Happy New Year! Advenchen is excited to announce the initiation of APROMISS, a global phase 3 trial evaluating our novel small molecule tyrosine kinase inhibitor, AL3818, in recurrent or metastatic, advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS).