OK. Enough about the importance of individualized d0sing–and how well it works–for now. But trust me. We will revisit this issue often. And Gary, when you are ready to roll your program out, my legions of readers will be here to help!
Want to read an excellent, comprehensive review about the FDA committee hearings over whether or not to fast-track Kyprolis (carfilzomib) for FDA approval in July?
Here are a few excerpts from Reuters/Huffington Post:
I skipped around a lot. There is much more to read by going to:Kyprolis: FDA Advisers Back Blood Cancer Drug For Some Patients
By Anna Yukhananov SILVER SPRING, Md., June 20 (Reuters) – U.S. drug advisers backed Onyx Pharmaceuticals Inc’s drug for patients who have failed to successfully treat their blood cancer with other medicines, making it likely the drug would secure approval from U.S. regulators. A panel of outside advisers to the Food and Drug Administration voted unanimously to recommend approval of Onyx’s drug, to be sold as Kyprolis, for treating multiple myeloma in people who have tried at least two other medicines. The FDA usually follows panel recommendations, although it is not required to, and will make a final decision by July 27… Analysts expect the multiple myeloma market to reach $5.4 billion by 2016, with carfilzomib – the chemical name of Kyprolis – garnering about $570 million if it is approved, according to Thomson Reuters forecasts… Panel members said the drug gave people another option to try to beat back the disease. “I do think this drug is beneficial to this patient population given the limited therapeutic options available,” said panel member Dr. Michael Menefee, assistant professor in hematology and oncology at the Mayo Clinic. The Onyx drug is a proteasome inhibitor with the same mechanism of action as Takeda Pharmaceutical Co Ltd’s Velcade, or bortezomib, a commonly used treatment for multiple myeloma available since 2003. Onyx said about a fifth of all myeloma patients have cancer that no longer responds to standard drugs, leaving room for another option. The company is seeking approval in only those people who have already tried at least two other myeloma treatments, including Velcade and Celgene Corp’s Revlimid or Thalomid, known chemically as thalidomide. About 23 percent of people taking Kyprolis had some response to it during clinical trials, and the response lasted for just under 8 months. Dr. Richard Pazdur, head of the FDA’s office of oncology, said the duration of response was significant, and suggested the drug had a unique way of targeting the cancer…