Multiple Myeloma

Cancer-Related Fatigue May Lead to Reduced Survival in Patients With Multiple Myeloma

(Journal Of Clinical Pathways) Sept 17, 2018 - A recent study found that cancer-related fatigue may predict worse progression-free survival (PFS) and overall survival (OS) among patients with newly diagnosed or relapsed/refractory multiple myeloma.

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Amgen Emerges As New Multiple Myeloma Drug Player, Threatening Bluebird, Celgene

(STAT Plus/Adam's Take) Sept 10, 2018 - Shares of Bluebird Bio and Celgene fell Monday on concerns their jointly developed cell therapy for multiple myeloma could be threatened by a novel antibody drug that emerged from Amgen’s pipeline this weekend. In an early stage clinical trial, four of five patients with multiple myeloma were treated with the Amgen therapy and had stringent “complete responses,” meaning they presented with no detectable disease. The patients, who had failed to respond to multiple lines of previous medicines, continued to show no detectable disease after 10 months of follow-up with the treatment, called AMG 420. The drug was well-tolerated.

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Poseida Provides Update on Phase 1 Study of P-BCMA-101 CAR-T Stem Cell Memory Product in Patients with Relapsed/Refractory Multiple Myeloma

(Morningstar) Sept 5, 2018 - Poseida Therapeutics Inc. announced data results from the first eleven patients treated in its ongoing Phase 1 study of its P-BCMA-101 stem cell memory chimeric antigen receptor T-cell (CAR-T) product in relapsed/refractory multiple myeloma.

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Genmab Announces European Marketing Authorization for DARZALEX® (daratumumab) for Front Line Multiple Myeloma

(Markets Insider) Aug 31, 2018 - Genmab A/S announced today that the European Commission (EC) has granted marketing authorization for DARZALEX® (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP), for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

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OPKO Health’s BioReference Laboratories to Participate in the National Cancer Institute NCI-MATCH (Molecular Analysis for Therapy Choice) Phase II Clinical Trial

(NASDAQ) Aug 28, 2018 - OPKO Health, Inc. today announced that BioReference Laboratories, Inc. (BRL), an OPKO Health company and the third largest clinical laboratory in the United States, has signed a collaboration agreement with the National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group (ECOG-ACRIN).

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Amgen Submits Supplemental New Drug Application For KYPROLIS® (carfilzomib) Once-Weekly 70 mg/m2 In Combination With Dexamethasone

(The Business Journals) Aug 27, 2018 - Amgen today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma.

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U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

(BMS) Aug 23, 2018 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The FDA granted the application priority review with an action date of December 27, 2018. “This file acceptance is an important step in BMS’s ongoing efforts to advance treatment options for patients with relapsed/refractory multiple myeloma,” said Jeffrey Jackson, Ph.D., hematology development lead, Bristol-Myers Squibb. “Given the need for new, effective treatment options in this patient population, we look forward to working with the FDA with the hope of bringing this combination to patients with RRMM whose disease progressed on previous therapies as quickly as possible.”

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Bristol-Myers: FDA To Review SBLA For Empliciti With Pomalidomide, Dexamethasone

(NASDAQ/RTTNews.com) Aug 23, 2018 - Bristol-Myers Squibb Company announced the U.S. FDA accepted its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

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NUS Researchers Develop AI Platform To Rapidly Identify Optimal Personalised Drug Combinations For Myeloma Patients

(NUS [Singapore]) Aug 13, 2018 - A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug combination for a patient quickly.

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Sutro and The Leukemia & Lymphoma Society Partner on Lymphoma and Multiple Myeloma Treatment

(Markets Insider) Aug 13, 2018 - Sutro Biopharma, Inc., and The Leukemia & Lymphoma Society® , or LLS, are partnering to develop STRO-001, Sutro's CD74-targeting antibody-drug conjugate, to treat relapsed and/or refractory multiple myeloma and non-Hodgkin's lymphoma.

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Mount Sinai Researchers Create RNA and DNA-Sequencing Platform to Match Broader Swath of Cancer Drugs to Patients With Few Options

(Mount Sinai) Aug 8, 2018 - A comprehensive RNA and DNA sequencing platform benefits late-stage and drug-resistant multiple myeloma patients by determining which drugs would work best for them, according to results from a clinical trial published in JCO Precision Oncology in August.

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Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX® (daratumumab) Split Dosing Regimen

(Markets Insider) Aug 8, 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regimen for DARZALEX® (daratumumab).

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Karyopharm Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma

(NASDAQ) Aug 6, 2018 - Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for selinexor, its novel, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma.

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FDA Grants Orphan Drug Designation to Surface Oncology’s SRF231 for the Treatment of Multiple Myeloma

(NASDAQ) July 30, 2018 - Surface Oncology, a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's lead investigational candidate SRF231 for the treatment of patients with multiple myeloma.

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CHMP Issues Positive Opinion Recommending DARZALEX® (daratumumab) for Front Line Multiple Myeloma

(NASDAQ) July 27, 2018 - Genmab A/S announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX® (daratumumab) in the European Union.

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New Tool for Assessing Frailty Predicts Survival in Newly Diagnosed Multiple Myeloma

(ASCO) July 25, 2018 - A new “frailty index” predicts overall survival for patients newly diagnosed with multiple myeloma, according to a study published on July 25 in JCO Clinical Cancer Informatics (JCO CCI). This tool is important because frailty is a critical factor in treatment decision-making for many patients with multiple myeloma, as the cancer most commonly arises among older adults. According to the authors, this tool is the first of its kind to assess frailty based on the accumulation of aging-associated diseases and disabilities—or biological age—rather than chronological age alone to predict overall survival in multiple myeloma. “Our goal was to create a tool that could be widely applied using data sources at hand and that helps doctors provide better-informed treatment recommendations for their patients,” said study author Tanya S. Wildes, MD, MSCI, of Washington University School of Medicine in St. Louis. “Our results demonstrate that, for patients with multiple myeloma, chronological age alone is not a good measure for assessing overall health.”

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SELLAS Receives Fast Track Designation from FDA for Galinpepimut-S for the Treatment of Patients with Multiple Myeloma

(NASDAQ) July 20, 2018 - SELLAS Life Sciences Group Inc., a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's lead asset, galinpepimut-S (GPS), for the treatment of multiple myeloma (MM).

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Former Major League Baseball (MLB) All-Stars Dave Winfield And Steve Garvey Team Up With Amgen To Launch Myeloma MVP™ And Encourage Patients To Create Their Most Valuable Plan For Managing Multiple Myeloma

(Amgen) July 18, 2018 - Amgen today announced the launch of Myeloma MVPTM, a national campaign to help those affected by multiple myeloma create their Most Valuable Plan, an individualized approach for managing their disease.

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Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma

(StreetInsider) July 18, 2018 - Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, today announced that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for selinexor, its novel, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma.

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Looking At The Urine And Blood May Be Best In Diagnosing Myeloma

(Augusta University/Jagwire News) July 13, 2018 - When it comes to diagnosing a condition in which the plasma cells that normally make antibodies to protect us instead become cancerous, it may be better to look at the urine as well as the serum of our blood for answers, pathologists say.

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