Leukemia (includes ALL, AML, APL, CLL, CML, MDS, Myeloproliferative Disorders, Myelofibrosis)

Incyte to Present Diversified Development Portfolio and Opportunities for Accelerated Growth at 2018 Investor and Analyst Event

(Incyte) June 21, 2018 - Five late-stage oncology product candidates being developed in 15 different indications have the potential to significantly accelerate near-term revenue growth; pivotal REACH1 study of Jakafi® (ruxolitinib) in steroid-refractory acute GVHD met primary endpoint; sNDA submission expected in the third quarter of 2018.

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Incyte Announces REACH1 Pivotal Trial Meets Primary Endpoint of Overall Response Rate for Ruxolitinib (Jakafi®) in Steroid-Refractory Acute Graft-Versus-Host Disease

(Morningstar) June 21, 2018 - Incyte Corporation today announced positive topline results from its ongoing pivotal Phase 2 REACH1 trial evaluating ruxolitinib (Jakafi®) in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease (GVHD).

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Amgen Receives European Commission Approval To Add Overall Survival Data To BLINCYTO® (blinatumomab) Label

(Amgen) June 19, 2018 - Amgen today announced that the European Commission (EC) has granted a full marketing authorization for BLINCYTO® (blinatumomab) based on the overall survival (OS) data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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Celyad Doses First AML Patient at Final Dose Level in CYAD-01 THINK Trial and Begins Dosing First Patient With Second Cycle of Therapy

(Morningstar) June 19, 2018 - Celyad, a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced the first Acute Myeloid Leukemia (AML) patient was dosed with the first injections at the third and final dose level of CYAD-01 in the hematological arm of the Phase 1 THINK trial.

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Novel CD22 CAR-T Works After CD19 Product Failed

(Medscape Medical News) June 18, 2018 - A novel CAR T-cell therapy directed against CD22 worked in children with acute lymphoblastic leukemia who had previously progressed after receiving CD19-directed CAR T-cell therapy.

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New Long-term Data Confirm Roche’s Gazyva/Gazyvaro Extends The Lives Of People With Chronic Lymphocytic Leukaemia Compared To Mabthera/Rituxan

(Roche) June 15, 2018 - Roche today announced data from the final analysis of the CLL11 study evaluating Gazyva®/Gazyvaro® (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL) which will be presented during the Presidential Symposium at the 23rd European Hematology Association (EHA) Annual Congress, 14 - 17 June, in Stockholm.

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Phase 3 QuANTUM-R Study Demonstrates Daiichi Sankyo’s Quizartinib Significantly Prolongs Overall Survival as Single Agent Compared to Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations

(Markets Insider) June 18, 2018 - Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that positive results from the pivotal QuANTUM-R phase 3 study of single agent quizartinib were presented today as a late-breaking oral presentation in the plenary program at the 23rd Congress of the European Hematology Association (EHA) in Stockholm, Sweden.

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Phase III Study Shows Quizartinib Prolongs Overall Survival For Patients With Deadly Type Of Relapsed Or Refractory AML

(MD Anderson) June 16, 2018 - A study led by The University of Texas MD Anderson Cancer Center revealed that the investigational drug quizartinib prolonged overall survival for patients with a deadly form of acute myeloid leukemia (AML) linked to a genetic mutation called FMS-like internal tandem duplications (FLT3-ITD).

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TG Therapeutics, Inc. Presents Phase 2 Data Evaluating Umbralisib in CLL Patients Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy at the 23rd Congress of the European Hematology Association (EHA)

(Morningstar) June 18, 2018 - TG Therapeutics, Inc., today announced an oral presentation of clinical data from its ongoing Phase 2 study evaluating umbralisib (TGR-1202), the Company’s PI3K delta inhibitor, in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) who are intolerant to prior BTK or PI3K delta inhibitor therapy. Data from this trial were presented over the weekend during an oral session at the 23rd Congress of the European Hematology Association (EHA).

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BioLineRx Presents New Overall Survival Data From Phase 2a Study for BL-8040 in r/r AML Patients

(Morningstar) June 18, 2018 - BioLineRx Ltd., a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that new data presented at the 23rd Annual Congress of the European Hematology Association (EHA), held in Stockholm, Sweden, shows that BL-8040, combined with high dose cytarabine (HiDAC), significantly enhanced overall survival in difficult-to-treat relapsed or refractory AML (r/r AML) patients in a Phase 2a clinical trial.

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Cellerant Therapeutics, Inc. Presents Phase 2 Results Showing CLT-008 Significantly Reduces Risk of Infections in AML Patients Undergoing Standard Induction Chemotherapy

(Morningstar) June 18, 2018 - Cellerant Therapeutics, Inc., a clinical-stage company developing innovative immunotherapies for hematologic malignancies and other blood-related disorders, presented results from its randomized controlled Phase 2 clinical trial of CLT-008 (romyelocel-L, human myeloid progenitor cells), an off-the-shelf cell therapy which does not require HLA matching intended to prevent bacterial and fungal infections during neutropenia.

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Geron Reports Imetelstat Oral Presentation at European Hematology Association Congress

(NASDAQ) June 18, 2018 - Geron Corporation today announced the oral presentation of updated data from the ongoing original Part 1 of IMerge, the Phase 2/3 trial of imetelstat in lower risk myelodysplastic syndromes (MDS).

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Verastem Oncology Presents Duvelisib Data at EHA 2018 Annual Meeting

(Verastem) June 16, 2018 - Phase Ib/II study of duvelisib in combination with FCR (dFCR) achieves ORR of 94% and 76% bone marrow MRD negativity in frontline therapy in younger CLL patients; duvelisib demonstrates robust clinical activity in CLL with 73% ORR and a median of 15 month PFS in the DUO crossover study of patients who became relapsed/refractory to ofatumumab in DUO™.

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Ziopharm Oncology Shares Slide 7% Premarket After FDA Places Clinical Hold On Cancer Trial

(MarketWatch) June 18, 2018 - Ziopharm Oncology Inc. said Monday the U.S. Food and Drug Administration has placed a clinical hold on a Phase 1 trial of a treatment for cancer.

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Geron Wants J&J To Continue A Drug Development Partnership, But New Data Weaken Its Case

(STAT Plus) June 18, 2018 - Geron, a California-based biotech working on a treatment for blood disorders, is still trying to convince Johnson & Johnson to commit millions of dollars more to advance the development of imetelstat, the biotech’s only pipeline product.

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AbbVie Announces New Undetectable Minimal Residual Disease Data from Phase 3 Relapsed/Refractory Chronic Lymphocytic Leukemia MURANO Trial of Venetoclax in Combination with Rituximab at 23rd European Hematology Association Annual Congress

(AbbVie) June 15, 2018 - AbbVie, a research-based global biopharmaceutical company, today announced the presentation of investigational data from a new analysis of undetectable minimal residual disease (uMRD) rates from the pivotal Phase 3 MURANO trial of venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, in combination with rituximab (VenR) in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).

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MorphoSys Presents Clinical Data with Blood Cancer Candidate MOR208 in Chronic Lymphocytic Leukemia at EHA 2018 Conference

(DigitalJournal.com) June 15, 2018 - MorphoSys AG today announced the presentation of clinical data from the exploratory phase 2 COSMOS trial. The trial evaluates MorphoSys's proprietary hemato-oncological drug candidate MOR208 in combination with the cancer drug idelalisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), who progressed on or were intolerant to ibrutinib therapy.

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MEI Pharma Presents Clinical Data on ME-401 at the European Hematology Association Congress

(MEI Pharma) June 15, 2018 - Initiation of registration study for ME-401 in patients with relapsed or refractory follicular lymphoma expected before year-end.

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Blueprint Medicines Announces Updated Data from Ongoing Phase 1 EXPLORER Clinical Trial of Avapritinib in Patients with Advanced Systemic Mastocytosis Showing Profound and Durable Clinical Activity

(Blueprint Medicines) June 15, 2018 - Blueprint Medicines Corporation today announced updated data from its ongoing Phase 1 EXPLORER clinical trial of avapritinib, a potent and highly selective KIT and PDGFRA inhibitor in development for patients with systemic mastocytosis (SM).

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Trial Produces Practice-Changing Findings for Some Children, Young Adults with Leukemia

(NCI/Cancer Currents Blog) June 14, 2018 - Adding the drug nelarabine (Arranon) to standard chemotherapy improves survival for children and young adults newly diagnosed with T-cell acute lymphoblastic leukemia (T-ALL), according to new results from an NCI-sponsored Children’s Oncology Group (COG) clinical trial.

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