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Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
November 16, 2018 at 10:52 AM EST
-First FDA-Approved Regimen in Frontline Peripheral T-Cell Lymphoma-
-FDA Approval Based on Results from the Phase 3 ECHELON-2 Clinical Trial; Data to be Presented at the 2018 ASH Annual Meeting-
-Application Approved Less Than Two Weeks After Submission Under FDA Real-Time Oncology Review Pilot Program-
“The current standard of care for initial treatment of peripheral T-cell
lymphoma is multi-agent chemotherapy. That treatment has not
significantly changed in decades and is too often unsuccessful in
leading to long-term remissions, underscoring the need for new
This is the sixth
“By participating in the FDA’s Real-Time Oncology Review process and
working closely with the
The ECHELON-2 data will be presented at the
The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with AVD. The most common adverse events of any grade that occurred in at least 20 percent of patients in the ADCETRIS plus CHP arm were peripheral neuropathy, nausea, diarrhea, neutropenia, lymphopenia, fatigue, mucositis, constipation, alopecia, pyrexia, vomiting and anemia. Serious adverse reactions occurring in at least two percent of ADCETRIS plus CHP-treated patients included febrile neutropenia, pneumonia, pyrexia and sepsis. Based on ECHELON-2 clinical trial results, prophylactic growth factors (G-CSF) should be administered starting at cycle one for patients receiving ADCETRIS plus CHP for previously untreated PTCL.
ECHELON-2 Phase 3 Clinical Trial Design
The multi-center, randomized, double-blind, placebo-controlled phase 3
trial is investigating ADCETRIS plus CHP (cyclophosphamide, doxorubicin,
prednisone) versus CHOP (cyclophosphamide, doxorubicin, vincristine,
prednisone) as frontline therapy in patients with CD30-expressing
peripheral T-cell lymphoma, also known as mature T-cell lymphoma. The
primary endpoint is progression-free survival (PFS) per BICR facility
assessment, with events defined as progression, death due to any cause,
or receipt of subsequent anticancer chemotherapy to treat residual or
progressive disease. Secondary endpoints include PFS in patients with
systemic anaplastic large cell lymphoma (sALCL), complete remission
rate, overall survival and objective response rate, in addition to
safety. The trial was conducted at sites across
Please see Important Safety Information, including Boxed Warning, at the end of this press release.
About T-Cell Lymphomas
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. 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 the estimated 74,680 people diagnosed with non-Hodgkin lymphoma in the U.S. in 2018.1
About ADCETRIS (brentuximab vedotin)
ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include the recently completed phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ECHELON-1 trial in previously untreated Hodgkin lymphoma, the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma, and the ongoing 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 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.
ADCETRIS (brentuximab vedotin) 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% 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 utilization of and
therapeutic potential of ADCETRIS (brentuximab vedotin) as a treatment
for adults with previously untreated systemic anaplastic large cell
lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas
(PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not
otherwise specified, the possibility that the approved regimen could
transform the way newly diagnosed CD30-expressing PTCL patients are
treated, and the anticipated presentation of data from the ECHELON-2
clinical trial at ASH in 2018. 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, the availability
and extent of reimbursement, the risk of adverse events and adverse
regulatory action. More information about the risks and uncertainties