FDA Requests Additional Information For Prolia Approval – Amgen Inc. announced on Monday that the U.S. Food and Drug Administration (FDA) has requested additional information needed for the agency to complete its review of Prolia (denosumab).  Amgen has applied to the FDA to have Prolia approved for the treatment and prevention of postmenopausal osteoporosis.  In its recent information request, the FDA asked Amgen for all updated Prolia safety data as well as more details about Amgen's proposed post-marketing surveillance program for Prolia.  The Agency also informed Amgen that a new clinical trial program will be necessary for the FDA to be able to approve Prolia for the prevention of postmenopausal osteoporosis. Prolia is currently being tested in multiple myeloma patients to see if it can delay skeletal events (see related Beacon article). For more information, please see the Amgen press release.

Race For Research 5K Walk/Run – On November 1, the Multiple Myeloma Research Foundation will be sponsoring the Race for Research 5K Walk/Run in Atlanta, Georgia. Registration starts at 7 a.m. and the race beings at 8:30 a.m. The MMRF is looking for participants and donations for this event. For more information, please visit the MMRF Web site.

RHS Open – On November 2, the International Myeloma Foundation is holding the Inaugural RHS open in Mt. Pleasant, SC. This annual golf tournament is held in honor of IMF Board Member, Rich Saletan. For more information, to register, or to sponsor a golfer, please visit the IMF Web site.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.