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Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Receives European Commission Approval for CD30-Positive Cutaneous T-Cell Lymphoma after at Least One Prior Systemic Therapy
January 22, 2018 at 8:00 AM EST
Approval Based on Positive Phase 3 ALCANZA Trial Results, which Demonstrated a Highly Statistically Significant Improvement in Rate of Objective Response Lasting at Least Four Months, Median Progression-Free Survival, and Improvement in Symptom Burden in ADCETRIS Arm
“CTCL is a debilitating and disfiguring disease with few effective and
durable treatment options,” said
The marketing authorization for ADCETRIS is valid in 28 countries of the
For further details about the
Lymphoma is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin
lymphoma and non-Hodgkin lymphoma. Cutaneous lymphomas are a category of
non-Hodgkin lymphoma that primarily involve the skin. According to the
ADCETRIS is being evaluated broadly in more than 70 clinical trials,
including three phase 3 studies: the completed ECHELON-1 trial in
frontline classical Hodgkin lymphoma that supported the recent
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 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)
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: peripheral sensory neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, 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, and for at least 6 months after the final dose of ADCETRIS treatment.
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of ADCETRIS (brentuximab vedotin) for uses for which ADCETRIS
has not received regulatory approval such as frontline Hodgkin lymphoma,
and our goal to establish ADCETRIS as the foundation of care in
CD30-expressing lymphomas. Actual results or developments may differ
materially from those projected or implied in these forward-looking
statements. Factors that may cause such a difference include the
possibility that the safety and/or efficacy results of our trial in
Hodgkin lymphoma will not be sufficient to gain marketing approval in