Available in the UK. 100mg powder for conc for soln for inf in vial, 1=£1,455 .
Approved in the UK .
Has been available in the US since Jan 20 .
Granted conditional approval in EU .
Recommended for EU approval by CHMP - the full indication is "for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens." It should be prescribed by physicians experienced in the use of anticancer medicinal products .
European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens and granted accelerated assessment .
EU filing based on DESTINY-Breast01 planned for H2 20 .
Analysts predict this will be one of the top 10 most-anticipated new US drug launches of 2020 based on estimated global sales in 2024 .
Filings based on data from DESTINY-Breast 02 expected in 2021 .
Approved in US via accelerated approval process, based on tumour response rate; continued licensing may be conditional on confirmation of clinical benefit .
Filed in US with priority review .
Filings based on DESTINY-Breast 01 planned for H2 2019 .
Filings planned for 2020+ .
US FDA grants Breakthrough Therapy Designation to trastuzumab deruxtecan for treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1) .
US FDA grants Fast Track designation to trastuzumab deruxtecan for treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine .