Beacon NewsFlashes - July 4, 2011

MDX-1097 Receives Orphan Drug Status For Multiple Myeloma – The Australian bio-therapeutic company Immune System Therapeutics announced last week that it has received orphan drug designation from the United States Food and Drug Administration (FDA) for its investigational drug MDX-1097. MDX-1097 is an antibody that binds to certain proteins on the surface of myeloma cells, triggering the immune system to kill the cancer cells. The FDA uses the orphan drug designation to promote the development of new treatments for rare diseases that affect fewer than 200,000 individuals in the United States. The orphan drug status provides the developer of the drug with several benefits, including funding for clinical trials and marketing exclusivity for up to seven years. For more information, please see the Immune System Therapeutics press release.
MD Anderson Cancer Center Announces Start Of Phase 1 Trial With Carfilzomib Plus Panobinostat In Myeloma – The MD Anderson Cancer Center announced last week that it will be starting a Phase 1 trial in early August to determine the highest tolerable dose levels of carfilzomib in combination with panobinostat (Farydak) in relapsed and refractory multiple myeloma patients. The safety of the combination treatment will also be assessed. Carfilzomib, which belongs to the same class of drugs as Velcade (bortezomib), is a new drug from Onyx Pharmaceuticals that is currently being investigated as a potential treatment for multiple myeloma. Panobinostat is an oral experimental cancer drug that is being developed by Novartis. For more information, please see the clinical trial description.
Music Against Myeloma – On Wednesday, July 13, several bands will play at Greenhouse in Manhattan to raise awareness and funds for multiple myeloma. The event starts at 8 p.m. and will feature live bands, drink specials, cupcakes, and more. All proceeds will go to the International Myeloma Foundation. For more information and tickets, please see the Music Against Myeloma website.
For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.
Related Articles:
- FDA Approves Once-Weekly Dosing And Revised Safety Information For Kyprolis
- Once-Weekly High-Dose Kyprolis Yields Deeper Responses And Longer Remissions Than Twice-Weekly Kyprolis (ASCO & EHA 2018)
- Eyelid-Related Complications Of Velcade Therapy: New Insights And Recommendations
- Dr. Christoph Driessen On Nelfinavir In The Treatment Of Multiple Myeloma
- Common Measures Of Heart And Blood Vessel Health May Predict Risk Of Heart-Related Side Effects During Treatment With Kyprolis
When you say accelerated FDA approval, what does that mean in real terms?