Seattle Genetics, Inc. SGEN today announced that Health Canada has
issued a Notice of Compliance with conditions (NOC/c), authorizing marketing
of ADCETRIS for two lymphoma indications: (1) the treatment of patients with
Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT)
or after failure of at least two multi-agent chemotherapy regimens in patients
who are not ASCT candidates, and (2) the treatment of patients with systemic
anaplastic large cell lymphoma (sALCL) after failure of at least one
multi-agent chemotherapy regimen. The indications for ADCETRIS were authorized
based on promising response rates demonstrated in single-arm trials. No data
demonstrate increased survival with ADCETRIS.
“We are focused on making ADCETRIS available globally to all eligible patients
with relapsed HL and sALCL. The approval of ADCETRIS in Canada, as well as the
recent approval in the European Union, are important milestones to accomplish
this goal,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer
of Seattle Genetics. “Now that Health Canada has approved ADCETRIS, we are
committed to working closely with public and private insurers to secure
reimbursement coverage for patients in Canada.”
“The approval of ADCETRIS in Canada marks a significant milestone for patients
with relapsed HL or sALCL who have had few new treatment options in several
decades,” Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for
Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada.
Health Canada grants NOC/c, a form of market approval, on the basis of
promising evidence of clinical effectiveness, for products intended for the
treatment of serious, life-threatening or severely debilitating illnesses that
meet a serious unmet medical need or demonstrate a significant improvement in
the benefit/risk profile over existing therapies. Conditions associated with
market authorization under the NOC/c policy include a requirement that Seattle
Genetics conduct clinical trials designed to confirm the anticipated clinical
benefit of ADCETRIS in these patients. Two confirmatory phase III clinical
trials evaluating ADCETRIS in the front-line treatment setting of HL and
mature T-cell lymphoma (MTCL), including sALCL, are currently underway and
enrolling patients.
ADCETRIS (brentuximab vedotin) was issued marketing authorization under the
NOC/c policy based on results from a single-arm, phase II pivotal trial in HL
patients with relapsed or refractory disease following an ASCT and a
single-arm, phase II pivotal trial in relapsed or refractory sALCL patients.
ADCETRIS is administered in hospitals through IV infusion over 30 minutes
every three weeks and patients who achieve stable disease or better should
receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately
one year).
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