Health Canada Approves ADCETRIS® (Brentuximab Vedotin) For The Treatment Of Relapsed Or Refractory Hodgkin Lymphoma (HL) And Systemic Anaplastic Large Cell Lymphoma (SALCL)
- ADCETRIS is the First in a New Class of Targeted Therapies Called Antibody-Drug Conjugates -
BOTHELL, Wash.--(BUSINESS WIRE)--Feb. 1, 2013-- Seattle Genetics, Inc. (Nasdaq: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).
ADCETRIS is the first in a new class of antibody-drug conjugates (ADCs) to be approved in Canada....
My daughter was on this drug in the USA and it actually worked very well. Unfortunately she relapsed from it however it looks like a very promising drug to at least help those in need to hopefully get to the next stage. The Canadian Government is a sad joke in the world of cancer and should be ashaimed of themselves. This drug was approved in the USA a while ago. What took our joke of a Country so long to approve this drug. Our #$%$ of a Government should automatically approve the drug once the USA approves it. God Bless the United States. This Country is a joke.
How many thousand more patients will be using Adcetris?
Does anybody know the rules in Canada for off label use of the drug? Will doctors use it in Canada in that fashion?
This should be a nice boost in sales over the next few quarters.
The number of patients eligible for this drug in Canada will be one-tenth or less of the number using it in the US.
Relatively few doctors will use it off-label, as relatively few people in Canada have insurance plans which provide coverage for drugs like this (coverage beyond that which the government already provides). Provincially, the drug will be publicly funded for limited indications (usually those which fall under the NOC/c).