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Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) for Primary Cutaneous Anaplastic Large Cell Lymphoma (pcALCL) and CD30-Expressing Mycosis Fungoides (MF)
November 9, 2017 at 12:40 PM EST
-MF and pcALCL Represent the Most Common Subtypes of Cutaneous T-Cell Lymphoma (CTCL)-
-FDA Approval Based on Clinical Trial Results from the Phase 3 ALCANZA and Phase 2 Investigator-Sponsored Studies in CTCL-
-Label Expansion Represents Fourth Indication for ADCETRIS in the U.S.-
This is the fourth
“Cutaneous T-cell lymphoma is a blood cancer of the skin with no known
cure and few new treatment options. It is a disfiguring disease in dire
need of more effective and durable treatment options to help keep this
debilitating and painful disease at bay,” said
“Our phase 3 ALCANZA clinical trial evaluating ADCETRIS in patients with
primary cutaneous anaplastic large cell lymphoma and mycosis fungoides,
which are the most common types of cutaneous T-cell lymphoma,
demonstrated superior efficacy with durable responses for long-term
disease management when compared to standard of care treatment options
methotrexate and bexarotene,” said
Additional data from two investigator-sponsored phase 2 trials evaluating ADCETRIS in 73 MF patients were also incorporated into the supplemental BLA representing a broader spectrum of CD30-expression levels than that of the ALCANZA trial.
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
According to the
ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 and is being evaluated broadly in more than 70 clinical trials, including three phase 3 studies: the ECHELON-1 trial in frontline classical Hodgkin lymphoma from which positive top-line results were recently reported, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, and the recently initiated 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 was granted conditional marketing authorization by the
ADCETRIS has received marketing authorization by regulatory authorities in 68 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 and our goal is 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 inability to show sufficient activity for uses
that have not received regulatory approval, the risk of adverse events,
and adverse regulatory action. More information about the risks and
uncertainties faced by