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Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Stage III or IV Classical Hodgkin Lymphoma
March 20, 2018 at 12:48 PM EDT
First FDA-Approved Regimen in Frontline Stage III or IV Classical Hodgkin Lymphoma in More Than 40 Years
FDA Approval Based on Clinical Trial Results from the Phase 3 ECHELON-1 Clinical Trial
Label Expansion Represents Fifth Indication for ADCETRIS in the U.S.; ECHELON-1 Trial Also Converts Prior Accelerated Approval to Regular Approval in Treatment of Relapsed Systemic Anaplastic Large Cell Lymphoma
“The standard of care for treating newly diagnosed advanced Hodgkin
lymphoma has not changed in more than four decades. For years, the
physician community has been conducting clinical trials to identify
improved regimens that are both less toxic and more effective to no
This is the fifth
“Currently, up to 30 percent of newly diagnosed advanced-stage classical
Hodgkin lymphoma patients will experience disease progression after
treatment with the current standard of care, representing a significant
need for improved treatment options for these often younger patients,”
About Classical Hodgkin Lymphoma
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. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.
According to the
ADCETRIS is being evaluated broadly in more than 70 clinical trials, including two ongoing phase 3 studies: the ECHELON-2 trial in frontline mature T-cell lymphomas and the 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 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.
ADCETRIS (brentuximab vedotin) U.S. Select 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.
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the potential
utilization of ADCETRIS (brentuximab vedotin) for patients with
previously untreated Stage III or IV classical Hodgkin lymphoma. Actual
results or developments may differ materially from those projected or
implied in these forward-looking statements due to factors such as
utilization and adoption of the approved treatment regimen by
prescribing physicians, competitive conditions including the
availability of alternative treatment regimens, the availability and
extent of reimbursement, the risk of adverse events, and adverse
regulatory action. More information about the risks and uncertainties