FDA Approves Fast Track Status for Perifosine in Refractory Advanced Colorectal Cancer
By Yael Waknine
Medscape Medical News
April 6, 2010 — The US Food and Drug Administration (FDA) has approved Fast Track designation for perifosine (made by Keryx Biopharmaceuticals, Inc, under license from AEterna Zentaris, Inc) in the treatment of refractory advanced colorectal cancer.
The FDA's Fast Track program is designed to provide facilitated development and expedited review of new drugs that address unmet medical needs in treating serious or life-threatening conditions.
Patients with recurrent or advanced colorectal cancer are often treated with concomitant or sequential administration of 2 or more of 7 approved drugs, including 5-fluorouracil (5-FU), capecitabine (Xeloda, Hoffmann-La Roche, Inc), irinotecan (Camptosar, Pfizer, Inc), oxaliplatin (Eloxatin, sanofi-aventis US, Inc), bevacizumab (Avastin, Genentech, Inc), cetuximab (Erbitux, ImClone Systems, Inc), and panitumumab (Vectibix, Amgen, Inc).
Patients with wild-type KRAS status who fail 5-FU-, oxaliplatin-, irinotecan-, and bevacizumab-containing therapies typically receive epidermal growth factor receptor monoclonal antibody therapy with cetuximab or panitimumab; no further treatment options are available if this treatment fails.
Perifosine is a novel, potentially first-in-class oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase pathway and also affects other key signal transduction pathways associated with apoptosis and cellular growth/differentiation. High levels of Akt activation have been observed with many cancer types and are linked to therapeutic resistance and poor prognosis.
According to a company news release, a randomized, double-blind phase 3 trial of perifosine in combination with capecitabine in patients with refractory metastatic colorectal cancer is expected to begin this quarter of 2010 under a special protocol assessment with the FDA.
"We now look forward to the initiation and sponsorship by our partner, Keryx, of this key registration Phase 3 trial in refractory metastatic colorectal cancer in North America which they expect to complete in 2011, with product launch, in the USA, in 2012," noted Juergen Engel, PhD, president and chief executive officer of AEterna Zentaris, in company news release. "These data will be very supportive of our efforts to register perifosine in the rest of the world, and in some countries, we expect they will be sufficient to do so without any additional studies."
Perifosine previously was granted Fast Track and orphan drug status by the FDA for the treatment of relapsed/refractory multiple myeloma and is currently in phase 3 trials under special protocol assessment for this indication.
