Multiple Myeloma

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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NICE Turns Down Darzalex Combo For Pre-Treated Multiple Myeloma

(PharmaTimes [UK] July 12, 2018 - Janssen says it is disappointed that NHS cost regulators are not backing NHS use of Darzalez (daratumumab) plus bortezomib and dexamethasone (DBd) for previously treated multiple myeloma in adults.

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Phase 3 Trial of NINLARO® (ixazomib) as Maintenance Therapy Met Primary Endpoint Demonstrating Statistically Significant Improvement in Progression-Free Survival in Patients with Multiple Myeloma Post-Transplant

(Morningstar) July 11, 2018 - Takeda Pharmaceutical Company Limited today announced that the randomized, Phase 3 TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral NINLARO® (ixazomib) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo.

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Cellectar Announces Expansion of Diffuse Large B-Cell Lymphoma Cohort in CLR 131 Phase 2 Trial

(Cellectar) June 28, 2018 - Cellectar Biosciences, Inc. today announces that the company will expand patient enrollment in the diffuse large b-cell lymphoma (DLBCL) cohort of its currently enrolling Phase 2 clinical trial of CLR 131.

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FDA to Release List of Surrogate Endpoints in Oncology

(Regulatory Focus) June 25, 2018 - Scott Gottlieb, FDA Commissioner, said Monday at the National Press Club in Washington, DC that his agency will release a list of surrogate endpoints used in cancer drug development soon.

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Can We Afford the Cost of Myeloma Therapy?

(Medscape Medical News) June 25, 2018 - Two experts square off on the issue of drug cost for multiple myeloma -- is care really not affordable, or are most patients able to access treatment?

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Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone Reduces the Risk of Disease Progression by 46% Versus Pomalidomide/Dexamethasone Alone in Patients with Relapsed or Refractory Multiple Myeloma

(BMS) June 17, 2018 - Primary endpoint of progression-free survival met for the combination of Empliciti plus pomalidomide and low-dose dexamethasone; data will be presented for the first time in late-breaking oral session during the 23rd Congress of the European Hematology Association.

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Molecular Partners Says 5 Of 8 Patients Responded In Multiple Myeloma Trial

(Reuters) June 15, 2018 - Molecular Partners said on Friday that five of eight patients with advanced multiple myeloma in a Phase II study showed an objective response to a combination therapy that includes an investigational drug from the Swiss company.

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Molecular Partners Presents Updated Results From Its Ongoing Phase 2 Combination Study Of Its Lead Oncology Drug MP0250 At EHA In Stockholm

( June 15, 2018 - MP0250 is evaluated in combination with Velcade/Dexamethasone (VelDex) in relapsed/refractory multiple myeloma (MM) patients; five of eight patients (62.5%) with relapsed/refractory multiple myeloma showed an objective response to MP0250 plus VelDex; median duration on treatment for patients with response was 22.5 weeks.

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Karyopharm Presents Updated Selinexor Phase 1b/2 STOMP Myeloma Data from Multiple Combinations at the European Hematology Association 2018 Annual Meeting

(Morningstar) June 15, 2018 - Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, today announced that three posters highlighting clinical data from the ongoing Phase 1b/2 STOMP study in patients with multiple myeloma (MM) will be presented at the European Hematology Association (EHA) 2018 Annual Meeting taking place June 14-17, 2018 in Stockholm, Sweden.

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Trillium Therapeutics Doses First Patient With TTI-622, Its Second Immune Checkpoint Inhibitor Targeting CD47

(Morningstar) June 14, 2018 - Trillium Therapeutics Inc. announced today that it has initiated dosing in its phase 1 clinical trial of TTI-622 (SIRPaFc-IgG4), a checkpoint inhibitor of the innate immune system, in relapsed or refractory lymphoma or myeloma.

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Mayo Clinic Patient Treated By Massive Measles Dose Still Cancer-Free 5 Years Later

(Minneapolis Star-Tribune) June 10, 2018 - Mayo Clinic patient from Pequot Lakes is living "proof of concept" for doctor's efforts to advance the use of viruses as a way to target cancers.

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FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To KYPROLIS® (carfilzomib) Label

(Amgen) June 11, 2018 - Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for KYPROLIS® (carfilzomib).

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Janssen Sees A Potential Myeloma CAR-T edge, Exec Says at BIO

(MedCity News) June 7, 2018 - Although bluebird bio’s CAR-T cell therapy for multiple myeloma is already in a registration-directed clinical trial, Janssen sees plenty of room to muscle in as well.

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Best of European Biotech at ASCO 2018

( June 6, 2018 - Not able to attend the biggest cancer conference of the year? No problem. We have summarized what we think are the most interesting therapy developments presented by European biotech’s at ASCO this year.

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PharmaMar Presents in Oral Session at ASCO: The ADMYRE Study's Adjusted Overall Survival With Plitidepsin

(PharmaMar) June 5, 2018 - PharmaMar has presented today how crossover has had an influence on the overall survival of the ADMYRE trial. The impact on overall survival of those patients that relapsed after receiving dexamethasone as a single agent and who were subsequently treated with plitidepsin in combination with dexamethasone was analyzed.

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As CAR-T Treatments Advance, Washington Grapples With Ideas For How To Pay For Them

(STAT Plus) June 5, 2018 - They are among the most promising new cancer therapies available, but they come with sky-high prices to match. And now the Trump administration is grappling with just how the federal government, through Medicare and Medicaid, will pay for them.

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Investor Update: Roche Presents New Data Across A Range Of Blood Cancers At The 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

(Roche) June 3, 2018 - Roche presented new data from studies in several blood cancers, including diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukaemia (CLL) and acute myeloid leukaemia (AML) at the 2018 ASCO Annual Meeting, 1-5 June, in Chicago, IL, United States.

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Bluebird Myeloma Treatment Delays Cancer Progression: Trial

(Reuters) June 1, 2018 - Patients with advanced multiple myeloma treated with bluebird bio’s experimental immunotherapy lived for a median of nearly a year before their cancer worsened, according to data from a small study presented on Friday.

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