Validation confirms that the application is complete and commences the scientific review process by the EMA’s CHMP. Accelerated assessment is granted by the CHMP to products expected to be of major interest for public health and therapeutic innovation and can significantly reduce the review timelines.
“The accelerated assessment highlights the significant unmet need for patients with HER2 positive metastatic breast cancer that trastuzumab deruxtecan aims at addressing,” said
The MAA is based on the positive results from the pivotal phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecanmonotherapy in patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2 regimens. The results of the DESTINY-Breast01 trial are published in
About HER2
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including gastric, breast and lung cancers. HER2 overexpression is associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poorer prognosis.[i]
About HER2 Positive Breast Cancer
Approximately one in five breast cancers are HER2 positive.[ii],[iii]Despite recent improvements and approvals of new medicines, there remain significant clinical needs for patients with HER2 positive metastatic breast cancer.[iv],[v] This disease remains incurable with patients eventually progressing after available treatment.[v]
About Trastuzumab Deruxtecan
Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the
ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is comprised of a HER2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker.
Trastuzumab deruxtecan (5.4 mg/kg) is approved in the
Trastuzumab deruxtecan has not been approved in the EU, or countries outside of
About the Trastuzumab Deruxtecan Clinical Development Program
A comprehensive development program for trastuzumab deruxtecan is underway globally with six pivotal trials evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 cancers including breast, gastric, and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.
In
In
About the Collaboration between
In
Aiheesta suomeksi
- Euroopan lääkevirasto (EMA) on myöntänyt nopeutetun arvioinnin Trastuzumab deruxtecanin myyntiluvalle. Nopeutettu arviointi voidaan myöntää tuotteille, joiden odotetaan olevan erityisen kiinnostava kansanterveyden kannalta.
- Trastuzumab deruxtecania käytetään HER2-positiivisen levinneen rintasyövän hoitoon. Sitä käytetään erityisesti potilaille, jotka ovat saaneet kahta tai useampaa aikaisempaa HER2-reseptoriin suunnattua täsmähoitoa.
- Trastuzumab deruxtecan on jo käytössä HER2-positiivisen levinneen rintasyövän hoidossa Yhdysvalloissa ja Japanissa.
References :
[i] Iqbal N, et al. Mol Biol Int. 2014; 2014: 852748
[ii] Tandon A, et al. J Clin Oncol. 1989;7(8):1120-8.
[iii] Sledge G, et al. J Clin Oncol. 2014;32(19):1979-1986.
[iv] de Melo Gagliato D, et al. Oncotarget. 2016;7(39):64431-46.
[v]National Comprehensive Cancer Network (NCCN). NCCN Guidelines. Breast Cancer. Accessed
© STT Info Finland, source