Date: 2017-08-29
Type of information: Granting of the Breakthrough Therapy status
Product name: DS-8201
Compound:
Therapeutic area: Cancer - Oncology
Action mechanism:
- antibody drug conjugate. DS-8201 is an investigational antibody drug conjugate comprised of a humanized anti-HER2 antibody attached by a peptide linker to a novel topoisomerase I inhibitor, utilizing Daiichi Sankyo’s proprietary payload and linker-payload technology.
Company: Daiichi Sankyo (Japan)
Disease: 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)
Latest news:
- • On August 29, 2017, Daiichi Sankyo announced that the FDA has granted Breakthrough Therapy designation to DS-8201 for the 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).
- The Breakthrough Therapy designation was granted based on the results of the ongoing phase 1 study assessing the safety, tolerability and preliminary efficacy of DS-8201. In the phase 1 study, no dose limiting toxicities were observed, and the maximum tolerated dose was not reached. Preliminary results of DS-8201 from a subgroup analysis of HER2-expressing metastatic breast cancer pre-treated with trastuzumab, pertuzumab and T-DM1 were recently presented at the 2017 American Society of Clinical Oncology (ASCO) annual meeting.
- In addition to Breakthrough Therapy designation, the FDA has granted Fast Track designation to DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
