In fiscal year 2011, FDA approved 7 “new molecular entities” (NMEs) in oncology.
1. Zytiga (albiraterone acetate) for late-stage prostate cancer.
Importance: Prostate cancer is the most commonly diagnosed cancer in men, and second only to lung cancer in the number of cancer deaths. In 2007, over 200,000 men were diagnosed with prostate cancer, and almost 30,000 died from it. Zytiga is the first in a new class of drugs to treat late-stage prostate cancer. Zytiga was shown to prolong the survival of certain late-stage prostate cancer patients, whose cancer is “castration-resistant,” when given in combination with prednisone (a steroid). Castration-resistant cancers are those that grow even when drugs or surgery are used to reduce testosterone levels or block its effects in the body. The ability of Zytiga to prolong survival in these patients is significant because they have few other treatment options.
Actions by FDA to speed drug testing and review: Zytiga’s safety and effectiveness were established in a clinical trial of 1,195 patients with late-stage castration-resistant prostate cancer who had received prior treatment with docetaxel chemotherapy. FDA did not require the sponsor to replicate the study findings in a second trial. The study was designed to measure overall survival, the length of time from when the treatment started until a patient’s death. A planned mid-study analysis showed that patients who received the Zytiga and prednisone combination had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone combination. Because of these convincing findings, the trial was terminated early, and approval was based on the early results. Zytiga was reviewed under the FDA’s priority review program, which provides for an
expedited six-month review of drugs.
Safety issues: FDA concluded that the benefits of Zytiga outweighed the risk of reported side effects, which include joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.
Source: FDA - FY 2011 Innovative Drug Approvals