Genta Chief Defends FDA
Robert Langreth, 11.06.02, 12:00 PM ET
NEW YORK - Drug and biotech industry executives have relentlessly attacked the U.S. Food and Drug Administration recently for its perceived slowness in approving new drugs. The accusation is that overcautious bureaucrats are delaying important new treatments for cancer and other deadly diseases with excessive demands for exhaustive data documenting safety and efficacy.
But one top cancer researcher and biotech executive is defending the agency. Genta (nasdaq: GNTA - news - people ) Chief Executive Raymond P. Warrell Jr. says that the agency should maintain its standard of demanding rigorous proof of new cancer drugs' efficacy from controlled clinical trials. "You are seeing a dumbing down of regulatory powers. Everyone is pretending the FDA is being really difficult, but what I am seeing overall is that if anything the FDA is being more accommodating," Warrell says. While this may get some good drugs to market faster, the downside, he adds, is that drugs may slip through that don't really work. In the long run, this hurts both patients and other companies that are committed to performing more rigorous trials.
Warrell, who was a top oncologist at New York City's Memorial Sloan-Kettering Cancer Center before taking the helm at Genta, a biotech firm based in Berkeley Heights, N.J., places the blame for some of the recent delays on companies' aggressive attempts to get their drugs approved without first conducting large-scale trials. For example, ImClone Systems (nasdaq: IMCL - news - people ) and marketing partner Bristol-Myers Squibb (nyse: BMY - news - people ) tried to get their colon cancer drug Erbitux approved last year on the basis of one small trial of 120 patients with no control group. The traditional procedure would have been to first conduct larger trials in several hundred patients comparing the experimental drug to standard treatment, and only then to seek approval. Last December the FDA refused to consider ImClone's application, citing flaws in the trial. The two companies recently announced plans for several new large trials of Erbitux, but it is still not clear when--or if--Erbitux will be approved.
Warrell says that Erbitux's troubles validate his more conservative approach to testing Genta's Genasense drug, now in final-stage testing for melanoma, lymphoma and multiple myeloma. Two years ago, Warrell made a somewhat controversial decision to forego testing Genasense in the type of midsize trials that backfired for Erbitux. He figured that smallish trials with no control group too often yield ambiguous data.
Instead, Genta skipped directly to large-scale "phase-III" trials comparing Genasense to standard chemotherapy on many hundreds of patients in an all-or-nothing bet to prove the drug worked. At the time, some on Wall Street complained that he was passing up a potential shortcut to approval by not conducting midsized trials, or so-called phase-II trials (the second of three usual phases of trials). "I have taken a lot of abuse for doing the correct trials," he says. Now he argues that his approach could end up being both lower risk and lower cost than ImClone's strategy.
Genta's melanoma, leukemia and myeloma trials are all nearing completion, and the company along with partner Aventis (nyse: AVE - news - people ) hope to file for approval of Genasense in the summer of next year. Genasense, which is used in combination with chemotherapy, works by targeting a key "cell suicide" gene called bcl-2 and then inducing cancer cells to kill themselves.
Separately, Dr. Warrell said that the FDA faced "a tough call" in whether or not to approve the lung cancer drug Iressa from British drugmaker AstraZeneca (nyse: AZN - news - people ), which is now in the late stages of regulatory review. On the one hand, when used alone, Iressa has induced dramatic remissions in a small number of patients who have been failed by other drugs. But two very large trials combining Iressa with chemotherapy utterly failed to show that Iressa increases survival versus chemo alone. Moreover, in the last few weeks, Iressa has been linked to 39 deaths in Japan from interstitial pneumonia, a rare lung disorder. AstraZeneca has argued that the chemotherapy might somehow have cancelled out the benefits or Iressa, but Warrell is uncertain. "There is no precedent in oncology to say that a drug would work alone but not with standard chemo," he says. "It is simply spin." |
