THE "NEW" PROSTATE CANCER INFOLINK

Apparently the U.S. Food & Drug Administration (FDA) has canceled a  meeting of the Oncology Drugs Advisory Committee (ODAC) that had been scheduled for February 9. The meeting was originally intended to discuss issues related to a biologics license application for ipilimumab (trade name Yervoy™).

The “New” Prostate Cancer InfoLink believes that the cancellation of this meeting of ODAC implies that we can expect to see the FDA approve the marketing of ipilimumab relatively early in 2011. According to the FDA the meeting was canceled “because the issues for which the FDA was seeking the scientific input of the committee have been resolved.”

The initial indication of ipilimumab will have nothing to do with prostate cancer. This interesting new drug will initially be approved for the management of patients with advanced forms of melanoma (an aggressive type of skin cancer characterized by the development of dark, uneven, mole-like lesions). However, there have been some interesting data reported on the activity of ipilimumab in high-risk and progressive prostate cancer.

Ipilimumab is currently in clinical trials for the treatment of several stages of prostate cancer. Examples of these trials include:

• A large, randomized, double-blind, Phase III trial of ipilimumab vs. a placebo in men with asymptomatic or minimally symptomatic, metastatic, chemotherapy-naïve, castration-resistant prostate cancer (CRPC) — still recruiting patients
• A large, randomized, double-blind, Phase III trial of ipilimumab vs. a placebo to be given after radiation therapy in men with progressive, metastatic prostate cancer who have already been treated with docetaxel-based chemotherapy — still recruiting patients
• A smaller, randomized, Phase II trial of combined androgen deprivation therapy (ADT) + ipilimumab vs. combined ADT alone in men with advanced prostate cancer — fully enrolled
• A small, non-randomized, Phase II trial of neoadjuvant ipilimumab + ADT in men with localized prostate cancer prior to a radical prostatectomy– still recruiting patients

If ipilimumab is approved for the treatment of melanoma, physicians will be at liberty to prescribe this drug “off-label” for the treatment of other appropriate conditions, potentially including prostate cancer. Of course insurance companies may not be willing to cover costs associated with ipilimumab therapy for prostate cancer until there are data clearly showing that it is effective and safe in the management of this condition.

Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment, Uncategorized | Tagged: approval, FDA, ipilimumab |