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ODAC Wants More Data on Expanded Casodex Indication

ODAC Wants More Data on Expanded Casodex Indication

BETHESDA, Maryland—Astra-Zeneca failed to gain backing from the FDA’s
Oncologic Drugs Advisory Committee (ODAC) for its effort to expand the
indication for Casodex (150 mg bicalutamide) in the treatment of prostate
cancer. ODAC members found that the data presented were too premature to
recommend that the FDA approve the company’s supplementary new drug
application. They suggested, instead, that the agency delay a decision until
longer-term data about the drug’s efficacy become available.

AstraZeneca is seeking approval of Casodex 150 mg as an adjuvant therapy
to radical prostatectomy and radiotherapy of curative intent in patients with
locally advanced nonmetastatic prostate cancer who have a high risk for
disease recurrence and as immediate treatment of localized nonmetastatic
prostate cancer in patients for whom therapy of curative intent is not
indicated.

Casodex in a 50-mg dosage is currently approved in the United States in
combination with a luteinizing hormone-releasing hormone (LHRH) analogue for
the treatment of stage D2 metastatic prostate cancer. In its 150-mg form, the
drug is approved for treating early-stage prostate cancer in more than 40
countries, including Canada. The availability of Casodex and its off-label
use in the United States clearly weighed on the minds of ODAC members.

"This drug is going to be used because it is available; we know the drug
is going to be imported from Canada," said George H. Ohye, the committee’s
nonvoting industry representative. He suggested that FDA grant Casodex 150 mg
accelerated approval, which would require the sponsor to conduct phase IV
postmarketing trials to further confirm the drug’s safety and effectiveness.

To support its application, Astra-Zeneca presented data from three
prospective, randomized, double-blind, placebo-controlled multicenter trials,
known as the Early Prostate Cancer (EPC) trial program, carried out in 23
countries with a total population of 8,113 patients. The three studies are as
follows:

  • Trial 23, a 2-year study of 3,292 patients treated in North America,
    primarily in the United States: 80% received radical prostatectomy and 20%
    radiation therapy.
  • Trial 24, a worldwide study of 3,603 patients but conducted mostly in
    Europe: 46% received radical prostatectomy, 19% radiation therapy, and 35%
    watchful waiting.
  • Trial 25, which consisted of 1,218 patients enrolled in Scandinavia:
    13% received radical prostatectomy, 6% radiation therapy, and 80% watchful
    waiting.

Both Trial 24 and 25 were extended to 5 years from the originally intended
2 years and are still in progress. The EPC studies had two major endpoints:
time to progression, the choice of AstraZeneca, and survival, which the FDA
preferred.

Casodex 150 mg reduced the clinical progression of prostate cancer at 3
years by 42% overall, as determined by bone scans, said William A. See, MD,
professor and chief of urologic surgery, Medical College of Wisconsin, who
presented efficacy data from the three trials on behalf of AstraZeneca.

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