Selinexor Receives Fast Track Designation from FDA

Selinexor Receives Fast Track Designation

from FDA

What Does This Mean for Canada

Selinexor (KPT-330) was recently granted a Fast Track designation by the US Food & Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy, according to Karyopharm Therapeutics, the manufacturer of the oral SINE (selective inhibitor of nuclear export) compound.

The Fast Track program is designed to accelerate the development, review, and approval of drugs that treat serious and life-threatening conditions.

Selinexor has a unique mechanism of action which links to and inhibits XPO1, a nuclear export protein, which leads to the accumulation of tumour suppressor proteins in the nucleus of the cell. This reinitiates and amplifies their tumour suppressor function, which investigators believe leads to the selective induction of apoptosis in cancer cells, while sparing normal cells.

According to Aldo Del Col, Co-founder and Chairman, Myeloma Canada, this decision by the FDA does not impact the Health Canada drug review process, but it does send a strong signal that a nimbler approval process is needed to accelerate the availability of treatments to address unmet medical needs. This is one of the heath policy initiatives being tackled by our advocacy team.

The Myeloma Canada Research Network (MCRN) has been playing a significant leadership role in the global clinical development of selinexor. The MCRN 005 (BOSTON) trial, led by Dr Nizar Bahlis from the University of Calgary, is a pivotal, randomized Phase III study in combination with Velcade® (bortezomib) and low-dose dexamethasone. The trial has been activated at the following centres:

Alberta

Tom Baker Cancer Centre/ Alberta Health Services - Calgary
Cross Cancer Institute / University of Alberta - Edmonton

British Columbia

Vancouver General Hospital - Vancouver

Nova Scotia

Queen Elizabeth II Health Sciences Centre - Halifax

Ontario

Princess Margaret Cancer Centre - Toronto

Quebec

Maisonneuve-Rosemont Hospital - Montreal
Royal Victoria Hospital / McGill University - Montreal
L'Hôtel-Dieu de Québec - Quebec City

Saskatchewan

Saskatoon Cancer Center - Saskatoon

For additional details, click here .

Thanks to the efforts of Myeloma Canada and the MCRN, eligible Canadian myeloma patients have the opportunity to participate in a growing number of clinical trials that are evaluating new and promising treatments.