The FDA's Oncologic Drugs Advisory Committee has unanimously voted, 16-0, that Promacta (eltrombopag) demonstrates a favorable risk-benefit profile for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP).
The vote took place at the ASCO Annual Meeting, where the advisory committee reviewed studies evaluating the safety and efficacy of eltrombopag, a once-daily oral treatment developed to induce the production of cells in the bone marrow to increase platelets. Clinical data were presented and discussed that support that eltrombopag increases platelet counts and in turn reduces bleeding.
Eltrombopag was recently granted Orphan Drug status for this indication. If approved, the novel oral thrombopoeitin receptor antagonist, would be the first oral short-term treatment for previously treated patients with chronic ITP.
In addition, the FDA approved the use of implantable beacon electromagnetic transponders with the Calypso System in external-beam radiation therapy for prostatectomy patients. The system, known as GPS for the Body, is comprised of tiny transponders that are implanted into a patient's prostate prior to therapy to track tumor movement. If the tumor moves out of range, clinicians are able to adapt therapy during daily treatment to ensure that treatments are delivered as prescribed to the cancerous tissue while avoiding adjacent healthy organs.
Previously, the system was cleared only for use in patients with an intact prostate; however, studies indicate that up to 20% of prostatectomy patients are diagnosed with recurrent prostate cancer following surgery and require adjuvant radiation therapy, the standard of care for patients with a high risk of prostate cancer recurrence or those in whom recurrence has been diagnosed.
© 2008 Lippincott Williams & Wilkins, Inc.