FDA fast-tracks pancreatic cancer drug
Immunotherapy treatment proves to be nontoxic
A nontoxic immunotherapy treatment for pancreatic cancer has been put on the fast track by the Food and Drug Administration (FDA).
Lorus Therapeutics announced in early June that its drug Virulizin has received the designation. The FDA’s fast-track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Virulizin currently is being studied in a double-blind, randomized Phase III clinical trial being conducted in North American medical centers, involving 350 patients with advanced (unresectable, recurrent, or metastatic) pancreatic cancer.
The benefits of the fast-track designation include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints. An applicant may use any or all of the components of fast track without the formal designation. Fast-track designation does not necessarily lead to a priority review or accelerated approval.
"The fast-track designation says that the FDA has determined that this drug has potential value for patients with serious conditions like pancreatic cancer," says Raafat Fahim, PhD, president and chief operating officer of Lorus Therapeutics, Toronto, Ontario. "Now they actually have to see the potential."
New treatment for a devastating’ cancer
Virulizin had been awarded Orphan Drug Status from the FDA in 2001. This means that the FDA will help to facilitate the drug’s development process by providing financial incentives and granting seven years of market exclusivity in the United States (independent of patent protection) upon approval of the drug. This status is given to drugs used in the treatment of diseases that afflict fewer than 200,000 patients annually in the United States.
Pancreatic cancer may account for a small percentage of all cancers, but it is particularly deadly. Untreated, the survival time from diagnosis is about four to four and a half months, Fahim says. "It’s a devastating cancer."
The standard therapy, gemcitabine HCl (Gemzar), typically prolongs the survival of the patient by about six to eight weeks, he adds. The chemotherapy treatment also has a lot of side effects. "Almost invariably, everyone who starts with Gemzar will stop the drug at some point, either because of toxicity or because it didn’t help to control the cancer."
On the other hand, Virulizin, which directly stimulates macrophages and enhances their ability to kill tumor cells, has been shown to be relatively safe. For this and other reasons, the FDA has asked Lorus to combine Virulizin with gemcitabine in clinical trials. "Combining Virulizin with another drug would not add to the side reactions profile of that drug," Fahim says.
Patients in the Phase III trial are being randomized to receive either treatment with gemcitabine or treatment with gemcitabine in combination with Virulizin. Those patients who fail or become refractory to gemcitabine then are treated with 5-fluorouracil (5-FU) or with 5-FU in combination with Virulizin in a second-line therapy. All study subjects will be monitored throughout the remainder of their lives.
"We hope the clinical trials will show that combining it with the standard therapy will add value to those patients," Fahim says.
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