Daratumumab (DARZALEX & #174;) Granted Breakthrough Therapy Designation by U.S. FDA for Use in Combination with Standard of Care Regimens for Patients with Multiple Myeloma
FDA action underscores potential clinical benefit of daratumumab as a backbone therapy in combination with either a proteasome inhibitor (PI) or an immunomodulatory agent for patients who have received at least one prior therapy. Marks the second Breakthrough Therapy Designation for daratumumab (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 26, 2016 Category: Hematology Source Type: news
IMF's Black Swan Research Initiative & #174;: ASCENT Trial
< p > Dr. Shaji Kumar of the Mayo Clinic in Rochester, Minnesota, discusses the exciting new Black Swan Research Initiative & reg; clinical trial: ASCENT, which stands for Aggressive Smoldering Cure Evaluating Novel Rx Transplant. < /p > < p > In the ASCENT trial (which will begin enrolling patients later this year), high-risk smoldering myeloma patients will receive intense therapy for two years. Dr. Kumar, lead investigator of the trial, says he hopes that researchers will be able to prove that it is safe to treat these patients and get them to a sustained MRD-negative status. < /p > (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 22, 2016 Category: Hematology Source Type: news
Upcoming Consensus on Minimal Residual Disease (MRD) Testing Confirms Black Swan Approach
The IMF's Black Swan Research Initiative® moves a major step forward with the imminent publication of new myeloma response criteria using minimal residual disease (MRD) testing. In his blog this week, IMF Chairman Dr. Brian Durie explains the significance of this consensus by more than 200 top myeloma experts and why it confirms the Black Swan approach, and offers a snapshot of MRD testing for patients wondering if it's ready for “prime time.” (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 15, 2016 Category: Hematology Source Type: news
iStopMM (Iceland Screens, Treats, or Prevents Multiple Myeloma)
In this video, Dr. Sirgurdur Kristinsson of the University of Iceland describes the exciting new Black Swan Research Initiative® study, iStopMM (Iceland Screens, Treats, or Prevents Multiple Myeloma). As part of the iStopMM study, 140,000 Icelanders over the age of 40 will have their blood samples tested for the precursor to multiple myeloma, or MGUS (monoclonal gammopathy of undetermined significance). If they test for MGUS, they are given the option to take part in a randomized clinical trial to treat or prevent the progression of MM. Dr. Kristinnson explains the four aims of this groundbreaking study in this video.&...
Source: International Myeloma Foundation - July 15, 2016 Category: Hematology Source Type: news
Big Data Sharing Is Fundamental to Our Research Success
Vice President Joe Biden's recent National Cancer Moonshot Summit concluded with the announcement of a “shared data initiative.” “The IMF's International Myeloma Working Group (IMWG) has been gathering and sharing data from all major myeloma institutions globally for more than a decade,” writes IMF Chairman Dr. Brian Durie in his blog this week. “And our Black Swan Research Initiative® is actively sharing data on our path to find the cure.” (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 8, 2016 Category: Hematology Source Type: news
View the slides and replay for the IMF's Post ASCO/EHA/IMWG Recap Teleconference!
Please join Brian G.M. Durie, MD as he explains what's new and exciting from the American Society of Clinical Oncology (ASCO), the European Hematology Association (EHA), and the International Myeloma Working Group Summit (IMWG). (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 7, 2016 Category: Hematology Source Type: news
View the slides for the IMF's Post ASCO/EHA/IMWG Recap Teleconference!
Please join Brian G.M. Durie, MD as he explains what's new and exciting from the American Society of Clinical Oncology (ASCO), the European Hematology Association (EHA), and the International Myeloma Working Group Summit (IMWG). (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 7, 2016 Category: Hematology Source Type: news
DARZALEX ™ (daratumumab) Approved by Health Canada as the First Human Anti-CD38 Monoclonal Antibody for the Treatment of Multiple Myeloma
Janssen Inc. announces Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving DARZALEX ™ (daratumumab) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are refractory to both a PI and an IMiD. Health Canada approved this product on the conditi on that Janssen Inc. carries out confirmatory trials to verify the clinical benefit of DARZALEX™. (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 6, 2016 Category: Hematology Source Type: news
DARZALEX™ (daratumumab) Approved by Health Canada as the First Human Anti-CD38 Monoclonal Antibody for the Treatment of Multiple Myeloma
Janssen Inc. announces Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving DARZALEX™ (daratumumab) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are refractory to both a PI and an IMiD. Health Canada approved this product on the condition that Janssen Inc. carries out confirmatory trials to verify the clinical benefit of DARZALEX™. (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 6, 2016 Category: Hematology Source Type: news
FDA Approves New Kyprolis & #174; (carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma
The Committee for Medicinal Products for Human Use (CHMP) —a division of the European Medicines Agency—recommended a change to the terms of the marketing authorization for Kyprolis & #174; (carfilzomib) for the treatment of relapsed multiple myeloma. As of July 3, 2016, CHMP approved Kyprolis in combination with dexamethasone alone to treat adult patients who have received at least one prior therapy. (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 5, 2016 Category: Hematology Source Type: news
FDA Approves New Kyprolis® (carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma
The Committee for Medicinal Products for Human Use (CHMP)—a division of the European Medicines Agency—recommended a change to the terms of the marketing authorization for Kyprolis® (carfilzomib) for the treatment of relapsed multiple myeloma. As of July 3, 2016, CHMP approved Kyprolis in combination with dexamethasone alone to treat adult patients who have received at least one prior therapy. (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - July 5, 2016 Category: Hematology Source Type: news
IMF Educates on Dangers of Limiting Access to Myeloma Treatment Options
Robin Tuohy, IMF Senior Director of Support Groups, and her husband Michael Tuohy, a 16-year myeloma survivor and active patient advocate, appeared at a congressional briefing in Washington DC this week. They shared the perspective of patients and caregivers on the myeloma treatment guidelines that were recently proposed by the Institute for Clinical and Economic Review (ICER). The briefing was organized by the Partnership to Improve Patient Care (PIPC). Robin spoke of her family's journey in coping with Michael's illness. She also addressed how the proposals recommended in the ICER Report to the Center for Medicare an...
Source: International Myeloma Foundation - June 24, 2016 Category: Hematology Source Type: news
Register Today for the IMF's Post ASCO/EHA/IMWG Recap Teleconference!
Please join Brian G.M. Durie, MD as he explains what's new and exciting from the American Society of Clinical Oncology (ASCO), the European Hematology Association (EHA), and the International Myeloma Working Group Summit (IMWG). (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - June 23, 2016 Category: Hematology Source Type: news
Dr. Brian Durie: "ICER Blinks and Patients Benefit"
IMF Chairman Dr. Brian Durie calls the much-awaited Final Report from the Institute for Clinical and Economic Review (ICER) “less of a report than an admission that they do not have the expertise to adequately assess the complexities of new myeloma therapies.” In his blog this week, Dr. Durie notes that the report defers to the expertise of both doctors and patient advocates, and, importantly, that the International Myeloma Working Group has already launched an inclusive project to create treatment guidelines that can transform the cost/payer landscape. (Source: International Myeloma Foundation)
Source: International Myeloma Foundation - June 16, 2016 Category: Hematology Source Type: news
