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Seattle Genetics Announces More Than 30 Presentations at ASH 2018 Highlighting Progress with Broad ADCETRIS® (Brentuximab Vedotin) Development Program
November 1, 2018 at 4:05 PM EDT
-Positive Phase 3 ECHELON-2 Clinical Trial Results to be Presented in
Oral Session on
Data accepted for presentation at the ASH Annual Meeting include the following:
“There will be more than 30 data presentations from both corporate- and
investigator-sponsored studies presented at the 2018 ASH Annual Meeting
evaluating ADCETRIS in a variety of CD30-expressing lymphoma settings.
These presentations are reflective of a robust ADCETRIS clinical
development program that we, in partnership with the oncology community,
are conducting to improve the treatment outcomes for patients,” said
ADCETRIS is not currently approved for use in frontline PTCL or in combination with Opdivo.
Multiple corporate and investigator presentations will be featured at ASH. Abstracts can be found at www.hematology.org and include the following:
About ADCETRIS (brentuximab vedotin)
ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include the recently completed phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ECHELON-1 trial in previously untreated Hodgkin lymphoma, the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.
ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
ADCETRIS injection for intravenous infusion has received
ADCETRIS received conditional marketing authorization from the
ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.
ADCETRIS (brentuximab vedotin) Important Safety Information
BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML):
JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.
ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
Most Common (≥20%) Adverse Reactions: Neutropenia, anemia,peripheral sensory neuropathy, nausea, fatigue, constipation, diarrhea, vomiting, and pyrexia.
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin E (MMAE).
Use in Specific Populations
Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.
Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the submission of a
supplemental Biologics License Application (BLA) to the