GTx Fareston may find success in the prevention of prostate cancer-associated bone fractures

GTx Fareston may find success in the prevention of prostate cancer-associated bone fractures
Published:24-February-2009
By Datamonitor staff writer

GTx has filed a New Drug Application for Fareston in the prevention of bone fractures in prostate cancer patients treated with androgen deprivation therapy, which elevates the risk of fractures. The drug has shown efficacy in reducing this risk and approval in this indication may help to boost its flagging sales, provided an effective marketing strategy is implemented.

GTx plans to market Fareston for the prevention of bone fractures in prostate cancer patients.

A pivotal Phase III study, in which 1,389 prostate cancer patients treated with androgen deprivation therapy (ADT) were randomized to receive 80mg of GTx's Fareston or placebo, has produced positive results. The primary endpoint of the trial was new vertebral fractures. Secondary endpoints included bone mineral density, lipid changes and hot flashes. Patients treated with Fareston demonstrated a 53% reduction in incidence of vertebral fractures, compared to those on placebo. The drug also showed a favorable safety profile, with only 2% of patients experiencing adverse effects.

Fareston is a non-steroidal selective estrogen receptor modulator. It was launched in the US for the treatment of metastatic breast cancer in postmenopausal women with estrogen receptor-positive or unknown tumors in 1995. However, the drug failed to achieve a notable uptake in the breast cancer market.

Datamonitor forecasts the incidence of prostate cancer in the US to be over 419,000 in 2009. With an estimated 90% of advanced prostrate cancer patients receiving ADT, the potential market for Fareston is significant. Treatment with ADT can lead to bone loss, making prostate cancer patients susceptible to fractures, which can have a negative effect on survival.

Although Fareston has been available for many years, its use in breast cancer has not been extensive, as other drugs have overshadowed it. A potential approval for the prevention of bone fractures in prostate cancer patients on ADT may boost sales. However, Fareston's US patent is due to expire later this year. Patent expiry typically results in significant erosion of branded drug sales due to generic incursion. Yet as use of Fareston in breast cancer is low, generic competition may be minimal.

Therefore, to take advantage of this additional indication, GTx must invest substantially in an effective marketing strategy to ensure that the drug realizes its full commercial potential. Ongoing studies in the prevention of prostate cancer may then further expand Fareston's potential in this indication.
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