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Seattle Genetics Announces Progress in Expanding ADCETRIS® (Brentuximab Vedotin) Indications in Canada
May 3, 2019 at 12:09 PM EDT
-Health Canada Approves ADCETRIS in Combination with AVD Chemotherapy for the Treatment of Previously Untreated Hodgkin Lymphoma Based on Positive Phase 3 ECHELON-1 Clinical Trial Results-
-Supplemental New Drug Submission Completed for ADCETRIS in
Combination with CHP Chemotherapy in Frontline Peripheral T-Cell
Lymphoma based on Positive Phase 3 ECHELON-2 Clinical Trial Results and
Granted Priority Review Designation by
“The Health Canada approval of ADCETRIS in combination with AVD
chemotherapy in advanced-stage (Stage IV) Hodgkin lymphoma represents
the first major advance for patients in decades,” said
“Currently, up to 30 percent of newly diagnosed patients with
advanced-stage Hodgkin lymphoma will experience disease progression
after treatment with the current standard of care, representing a
significant need for improved treatment options,” said
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.
About T-Cell Lymphomas
There are more than 60 subtypes of non-Hodgkin lymphomas which are
broadly divided into two major groups: B-cell lymphomas, which develop
from abnormal B-lymphocytes, and T-cell lymphomas, which develop from
abnormal T-lymphocytes. There are many different forms of T-cell
lymphomas, some of which are extremely rare. T-cell lymphomas can be
aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for
approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and
ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma. The ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.
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) U.S. Important Safety Information
BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML):
ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).
Warnings and Precautions
Most Common (≥20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis
Concomitant use of strong CYP3A4 inhibitors or inducers 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 IV classical Hodgkin lymphoma and the
possibility that the supplemental New Drug Submission for ADCETRIS in
combination with chemotherapy in frontline PTCL could be approved, in
each case in