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New drug for superficial bladder cancer with better perspectives as the actual standards? Study design will be the most important aspect to get an approval for EOquin from Spectrum Pharmaceuticals.

September 13, 2007

Analysis of:Spectrum Pharmaceuticals Initiates Second Registrational Phase 3 Clinical Trial for EOquin(R) in Patients With Non-Invasive Bladder Cancer | www.pipelinereview.com

The phase 2 trial data presents results with a better outcome for superficial bladder cancer patients as those treated with standard procedures. A complete remission result after 2 years of 67% is dramatically better then adjuvant Chemoinstillation of immune therapy by BCG. The most important question for the near future will be. Is the study design innovative and can it prevent mistakes to exclude different risk distributions between the two or more groups compared in study. As a second important question the design in phase 3 with a comparison between placebo and EOquin is to week for FDA decisions because the comparison to established standard therapies in adjuvant treatment strategies are missing. The consequence will be that one or two more comparing arms in study should be integrated. This will be cost and time consuming but will prevent Spectrum Pharmaceuticals for the disaster of rejection of the collected data at the FDA after the period of data collection

To become a blockbuster drug in oncology is not depending on the amount of the effective dosage

June 4, 2007

Analysis of:Cancer Drug Is Effective at Lower Dose | online.wsj.com

Decision criteria to integrate new drugs in therapy strategies depend on the effectiveness and not on the question of the dosage. If prolongation of life in a palliative situation is possible and that under a best cost-effectiveness and minimal side-effects the treatment concept will be accepted as wide as possible. The industrial reimbursement will happen by the number of treatments and not by the calculation of milligrams sold. The study results encourage all oncologist to integrate this treatment as fast as possible into their treatment strategies against metastatic lung cancer.

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