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

May 14, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

(FDA.gov) Apr 10, 2019 - During the morning session, the committee will discuss new drug application (NDA) 211810 for pexidartinib capsule, submitted by Daiichi Sankyo, Inc. The proposed indication (use) for this product is for the treatment of adult patients with symptomatic tenosynovial giant cell tumor also referred to as giant cell tumor of the tendon sheath or pigmented villonodular synovitis, which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery.

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Moleculin Receives FDA Approval of Fast Track Designation for Annamycin

(Moleculin) Apr 18, 2019 - Moleculin Biotech, Inc. today announced that the U.S. Food and Drug Administration ("FDA") has approved its request for Fast Track Designation for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia ("AML").

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Affimed Provides Regulatory Update on AFM11 Clinical Program

(Associated Press) Apr 17, 2019 - Affimed N.V. today announced that it has submitted to the U.S. Food and Drug Administration (FDA) additional information to Affimed’s initial response document submitted in early March relating to the previously-announced clinical hold on AFM11.

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Computational Researchers And Oncologists Develop Protein Cancer Atlas To Accelerate Personalized Medicine For Leukemia Patients

(UTSA Today) Apr 17, 2019 - Only about one in four people diagnosed with acute myelogenous leukemia (AML) survive five years after the initial diagnosis. To improve that survival rate, researchers at UTSA and the University of Texas MD Anderson Cancer Center created an online atlas to identify and classify protein signatures present at AML diagnosis.

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Scanning For Cancer Treatment

(Harvard University) Apr 15, 2019 - Researchers combine CRISPR gene-editing technology with drug discovery to understand why treatment works (or doesn’t).

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Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS)

(Aprea) Apr 16, 2019 - Aprea Therapeutics, a privately held, clinical stage biopharmaceutical company developing novel anticancer therapies targeting the tumor suppressor protein p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to APR-246 for the treatment of patients with MDS having a TP53 mutation. In addition, FDA has also granted Orphan Drug Designation to APR-246 for treatment of MDS.

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New Cancer Therapies Offer Great Hope, But There Can Be Suprising Complications

(Washington Post) Apr 14, 2019 - When thinking about cancer therapy in recent years, Dorothy’s famous line from “The Wizard of Oz” comes to my mind: “We’re not in Kansas anymore.”

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Cancer-Killing Combination Therapies Unveiled with New Drug-Screening Tool

(UCSF) Apr 9, 2019 - UC San Francisco scientists have designed a large-scale screen that efficiently identifies drugs that are potent cancer-killers when combined, but only weakly effective when used alone.

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Astellas and Concerto HealthAI to Launch Real-World Evidence Initiative on Acute Myeloid Leukemia Focused on Improving Patient Treatment and Outcomes

(Markets Insider) Apr 10, 2019 - Concerto HealthAI, a leading Real-World Data (RWD), Artificial Intelligence (AI) technology and Outcomes Science company, announced a Real-World Evidence (RWE) initiative with Astellas Pharma Inc. to harness Concerto HealthAI's RWD in order to help focus on and benefit patients with FLT3 mutation-positive relapsed or refractory Acute Myeloid Leukemia (AML).

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Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA

(Celgene) Apr 5, 2019 - Celgene Corporation and Acceleron Pharma Inc. today announced that Celgene has submitted a Biologics License Application (BLA) for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. The submission is based on the safety and efficacy results of the pivotal phase 3 studies MEDALIST and BELIEVE, both recently presented at the American Society of Hematology annual meeting, where MEDALIST was included in the plenary session.

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Trovagene Announces Update to Phase 1b/2 AML Trial Data Presented at AACR - Additional Patients Achieve Complete Response at Two Highest Dose Levels of Onvansertib

(Markets Insider) Apr 5, 2019 - Trovagene, Inc. today announced updated data following its presentation at the American Association for Cancer Research.

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Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

(Morningstar) Apr 4, 2019 - Daiichi Sankyo Company, Limited today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib, an investigational FLT3 inhibitor, currently under Priority Review for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The new Prescription Drug User Fee Act (PDUFA) action date is August 25, 2019. The FDA extended the action date by three months to allow time to review additional data submitted by Daiichi Sankyo in association with an FDA request.

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A Step Toward Recovering Reproduction In Girls Who Survive Childhood Cancer

(University of Michigan) Apr 3, 2019 - Leukemia treatments often leave girls infertile, but a procedure developed by researchers at the University of Michigan working with mice is a step toward restoring their ability to be biological mothers.

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Tetraphase Pharmaceuticals Presents Preclinical Data on TP-2846, a Novel Drug Candidate for Acute Myeloid Leukemia

(Yahoo! Finance) Apr 3, 2019 - Tetraphase Pharmaceuticals, Inc. today announced data from its preclinical program for TP-2846, the Company’s new pipeline candidate for acute myeloid leukemia (AML) discovered using Tetraphase’s proprietary total synthesis platform.

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Bio-Path Holdings Presents Preclinical Data at American Association for Cancer Research Annual Meeting 2019

(BioSpace) Apr 3, 2019 - Bio-Path Holdings, Inc. announced that data from pre-clinical studies supporting the potential of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and acute myelogenous leukemia (AML) were presented at AACR 2019.

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Phase 1b/2 Dose Escalation Trial of Onvansertib in Relapsed/Refractory AML Demonstrates Safety, Tolerability and Relative Durability with Complete Responses at Highest Dose Levels

(Trovagene) Apr 1, 2019 - Greatest anti-leukemic activity has been observed in the onvansertib + decitabine arm, with complete response in 2 of 4 (50%) of evaluable patients from the two highest dose levels.

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AVEO and Biodesix Announce Positive Results from Phase Ib Ficlatuzumab-Cytarabine Trial in Patients with Relapsed and Refractory AML

(MarketWatch) Apr 1, 2019 - AVEO Oncology AVEO, and Biodesix, Inc. today announced results from an investigator-sponsored Phase Ib expansion cohort of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML).

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Targeted Drug for Leukemia Tested at Penn Medicine Helps Patients Live Longer

(Penn Medicine) Apr 1, 2019 - An inhibitor drug that targets a specific mutation in relapsed or refractory acute myeloid leukemia (AML) helps patients live almost twice as long as those who receive chemotherapy.

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Phase 3 ADMIRAL Trial Data Show XOSPATA® (gilteritinib) Significantly Prolongs Overall Survival in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia Compared with Salvage Chemotherapy

(Astellas Pharma) Apr 1, 2019 - Astellas Pharma Inc. today announced results from the Phase 3 ADMIRAL clinical trial comparing XOSPATA® (gilteritinib) to salvage chemotherapy in adult patients with relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation.

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Genomic Analysis Offers Roadmap For Diagnosis And Treatment Of A High-Risk Leukemia

(St. Jude Children’s) Mar 29, 2019 - An international collaboration led by St. Jude Children’s Research Hospital reveals the genomic basis of acute erythroid leukemia, an aggressive cancer with a dismal prognosis.

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