OncoGenex gets addditional “fast track” designation for custirsen

According to a media release from OncoGenex, the U.S. Food & Drug Administration has granted a “fast track” designation to the evaluation of data from the so-called AFFINITY trial of custiren + carbazitaxel + prednisone as a second-line treatment for men with metastatic, castration-resistant prostate cancer (mCRPC).

The Phase III AFFINITY trial was initiated in late 2012 and is scheduled to enroll a total of about 630 patients, all with mCRPC, and all randomized prospectively to treatment with either custiren + carbazitaxel + prednisone or a placebo + carbazitaxel + prednisone. Enrollment in the trial is ongoing at 94 different study centers around the world. Custirsen has previously also been known as OGX-011 and is also being studied in combination with docetaxel + prednisone in the SYNERGY trial. (The results of the SYNERGY trial are expected in the near future, i.e., some time this year.)

The primary endpoint for the AFFINITY trial is overall survival, and a secondary trial endpoint is progression-free survival at 140 days after initiation of therapy. The estimated completion date for this trial is December 2015.

The “fast track” approval process is designed– among other things — to expedite the review of drugs in clinical trials to treat serious conditions and fill an unmet medical need, and to get such new drugs to the patient earlier if appropriate trials clearly demonstrate at least adequate effectiveness and safety profiles.

2 Responses

  1. Speaking of cabazitaxel (Jevtana) , a buddy of mine starts chemo on Monday with a mix of decetaxel (Taxotere) + cabazitaxel (Jevtana).

    Jevtana was developed by Sanofi, which also makes Taxotere, as a second-line chemo after Taxotere fails. This is the first time I have heard of the combo being used upfront — be interested to know if any other regular followers have knowledge.

  2. Rick:

    I have never heard of this being done before. Are you sure your buddy is really starting on a regimen like this? It doesn’t sound like a very smart idea at all since the two drugs work in almost exactly the same ways. Could your buddy have possibly misunderstood what he was being told?

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