FDA Delays Anti-Leukemia Drug
by Frank Burroughs

Based on the astonishing evidence it has already reviewed, the Food and Drug Administration should immediately approve the leukemia drug dasatinib. Instead, it has scheduled an unnecessary hearing and vote by its Oncologic Drugs Advisory Committee, whose next meeting is not until June 2.

In the Phase 2 trial previously submitted for approval, 90% of patients received a complete hematological response, and adverse events were no worse

than the less effective drugs currently prescribed. Dasatinib uses advanced technology to target specific genetic malfunctions that cause chronic myeloid leukemia (CML) and certain forms of acute lymphoblastic leukemia (ALL). "Leukemia patients who have exhausted their options need Dasatanib today, not months from now. The FDA has already reviewed the compelling evidence of this drug's effectiveness, and the law allows them to make their own decision at any time.

"This is part of a disturbing trend of punting at the FDA," says Steve Walker, a senior advisor to the Abigail Alliance for Better Access to Developmental Drugs, which was founded by my 21-year-old daughter Abigail Burroughs prior to Abigail's death from head and neck cancer in June of 2001. Abigail's death followed a long battle to gain access to investigative drugs that, we now know, provided a reasonable chance for her survival. Today, the Abigail Alliance directly represents the interests of thousands of seriously ill patients who are denied access to investigative drugs by the current regulatory system.

Dasatinib is perhaps the best example yet of a new drug created from a solid understanding of the molecular causes of lethal forms of cancer. It is an early realization of the FDA's Critical Path initiative to speed the discovery and delivery of new medicines to patients who need them, now being vocally pushed by FDA's leadership but routinely ignored by staff level reviewers and their supervisors.

Without a Senate-confirmed administrator and senior leadership, the FDA's career employees are choosing to dither, often turning to advisory committees to validate even their most straight-forward decisions - a delaying tactic that stalls progress and hurts or even kills some patients.

The government must act now to avoid further unnecessary deaths, especially after the recent Federal appeals court decision ruling that the FDA does not have the right to deny terminally-ill patients access to drugs that have survived early tests for safety alone.

Frank Burroughs is President of the Abigail Alliance, a 501(c)3) charity entirely funded by small contributions and only representing patients fighting for their lives. www.abigail-alliance.org

Back to front page

Email the Editor