Dr. Maha Hussain (left) is calling for an open access program for Dendreon’s Provenge prostate cancer vaccine (Sipuleucel-T) pending completion of an ongoing, 500 man clinical trial, She made this suggestion March 29 during the FDA Advisory Committee hearing after voting “No” on the vaccine’s efficacy. She followed up with a letter to the FDA reiterating her “No” position and again calling for an open access program.

Dr. Hussain is the second oncologist among 4 members of the panel who voted “No” to the efficacy of the drug who has followed up with a letter to the FDA.
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Dr. Maha Hussain, an oncologist who was one of 4 out of 17 members of the FDA Advisory Committee to vote against accepting against the company’s claim to efficacy for Provenge (Sipuleucel-T) prostate cancer vaccine, is calling for an expanded access program to empower patients who want and need it to receive the drug while an ongoing 500 man clinical trial of Provenge is completed.
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A new blood test for detecting prostate cancer, ProstaMark® EPCA-2, is expected to enter large trials soon and may be available to the public in under 2 years. A study in the April issue of Urology presents evidence in support of EPCA-2 testing as a more accurate way to identify early stage and advanced cancer in the prostate. Full story