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FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Frontline Advanced Hodgkin Lymphoma
January 2, 2018 at 8:00 AM EST
-PDUFA Action Date
-Submission Based on Positive Results from the Phase 3 ECHELON-1 Clinical Trial-
-FDA Previously Granted Breakthrough Therapy Designation for ADCETRIS in Frontline Advanced Hodgkin Lymphoma-
“The FDA’s filing of our supplemental BLA with Priority Review
represents a significant milestone in our goal to redefine the frontline
treatment of advanced Hodgkin lymphoma,” said
The ECHELON-1 study evaluated a combination of ADCETRIS plus AVD
(Adriamycin, vinblastine, dacarbazine) compared to a recognized standard
of care chemotherapy regimen, ABVD (which includes bleomycin), in
frontline advanced classical Hodgkin lymphoma. The positive results from
the phase 3 ECHELON-1 trial were featured in the Plenary Scientific
Session of the 59th
ECHELON-1 Phase 3 Clinical Trial Design
Please see Important Safety Information at the end of this press release.
About Classical Hodgkin Lymphoma
According to the
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 was granted conditional marketing authorization by the
ADCETRIS has received marketing authorization by regulatory authorities in 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.
ADCETRIS (brentuximab vedotin) U.S. Important Safety Information
BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)
Warnings and Precautions
Most Common (≥20%) Adverse Reactions: peripheral sensory neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, and pyrexia.
Use in Specific Populations
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.