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

Trovagene Announces FDA Approval of IND for Phase 1b/2 Trial of PCM-075 in Patients with Acute Myeloid Leukemia

(Trovagene) July 27, 2017 - Trovagene, Inc., a precision medicine biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for PCM-075, a Polo-like Kinase 1 (PLK1) inhibitor, and has provided authorization to proceed with the treatment of patients with AML.

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New 3-year Data Supports Kite ‘Cure’ Hopes For CAR-T

(Pharmaphorum [UK]) July 21, 2017 - A handful of patients with aggressive leukaemia appeared to have been cured thanks to CAR-T therapy, with some living more than four years with complete remission (CR).

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Meeting Highlights From the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017

(EMA) July 21, 2017 - Positive recommendations on new medicines included Merck Serono’s Bavencio (avelumab) for the treatment of metastatic Merkel cell carcinoma; Novartis’ Rydapt (midostaurin) for the treatment of acute myeloid leukaemia, aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm and mast cell leukemia; and Roche’s Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic urothelial carcinoma and of non-small cell lung cancer.

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Roche Punts a PhI Cancer Drug Out Of The Pipeline And Back to Oryzon

(Endpoints News) July 20, 2017 - Little Oryzon Genomics in Spain picked up a considerable endorsement and financial support when Roche stepped in three years ago to partner on its lysine specific demethylase-1 (LSD1) inhibitor ORY-1001 (RG6016) for acute myloid leukemia and solid tumors.

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U.S. FDA Grants Orphan-Drug Designation to Astellas for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia

(Astellas) July 20, 2017 - Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation to gilteritinib in patients with acute myeloid leukemia (AML).

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Cancer And Kids: Is Medical Marijuana The Answer?

(Newsweek) July 18, 2017 - Medical marijuana for adults is still controversial. For children, it’s a live grenade. And possibly a lifesaver.

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CAR-T Cell Therapy Is Here To Stay

(Forbes/Guest Post) July 19, 2017 - After decades of research and development, we’re on the brink of a new era in the treatment of cancer, one where nearly every aspect—from the patient experience to the efficacy of treatments—may be upended.

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Sunesis Pharmaceuticals Announces First Patient Dosed in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia and other B-Cell Malignancies

(TheStreet) July 18, 2017 - Sunesis Pharmaceuticals, Inc. today announced that the first patient has been dosed at the Dana-Farber Institute in the Phase 1b/2 dose-escalation and cohort-expansion study of its reversible, non-covalent Bruton's Tyrosine Kinase (BTK)-inhibitor, SNS-062, in adults with chronic lymphocytic leukemia (CLL), small lymphocytic leukemia, Waldenstrom's macroglobulinemia and mantle cell lymphoma that have progressed after prior therapies.

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LLS Announces Expansion Of Precision Medicine Approach To Fight Blood Cancer

(LLS) July 19, 2017 - The Leukemia & Lymphoma Society (LLS) today announced the expansion of its groundbreaking precision medicine Beat AML® Master Trial, to test new, investigational treatments for acute myeloid leukemia (AML), the central initiative of LLS’s comprehensive assault on this deadly blood cancer affecting 20,000 Americans annually.

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Promising Results In Trial Of Engineered T Cells In High-Risk Leukemia

(Fred Hutch News Service) July 17, 2017 - Editor's note: This story was first published in Dec. 2016, when the results of this study were presented at the American Society of Hematology's annual meeting. It has been updated to reflect the researchers' publication on Monday of their results in the Journal of Clinical Oncology.

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Ligand Enters Into Commercial License and Supply Agreement with Amgen for Rights to Use Captisol in the Formulation of AMG 330

(PipelineReview.com) July 17, 2017 - Ligand Pharmaceuticals Incorporated today announced that it has entered into a commercial license and supply agreement with Amgen, granting rights to use Ligand’s Captisol technology in the formulation of AMG 330. Captisol is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.

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F.D.A. Panel Recommends Approval for Gene-Altering Leukemia Treatment

(New York Times) July 12, 2017 - A Food and Drug Administration panel opened a new era in medicine on Wednesday, unanimously recommending that the agency approve the first-ever treatment that genetically alters a patient’s own cells to fight cancer, transforming them into what scientists call “a living drug” that powerfully bolsters the immune system to shut down the disease.

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A Cancer Breakthrough Near FDA Approval Has a Costly Side Effect

(Bloomberg) July 12, 2017 - A breakthrough cancer therapy that can wipe out leukemia in some deathly ill children and young adults comes with an expensive, long-lasting side effect.

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Read the Archive of STAT’s Live Blog As We Analyzed A Crucial FDA Meeting On Experimental Car-T Cancer Treatment

(STAT) July 12, 2017 - The FDA is digging into the data on a revolutionary new approach to treating cancer. At stake: billions of dollars for pharma giant Novartis, a blockbuster race among biotech startups, and a potential breakthrough for patients with aggressive forms of cancer.

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Genetically Enhanced, Cord-blood Derived Immune Cells Strike B-cell Cancers

(MD Anderson) July 13, 2017 - Immune cells with a general knack for recognizing and killing many types of infected or abnormal cells also can be engineered to hunt down cells with specific targets on them to treat cancer, researchers at The University of Texas MD Anderson Cancer Center report in the journal Leukemia.

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FDA Advisory Board Gives Thumbs Up to Gemtuzumab for AML

(Medscape Medical News) July 12, 2017 - Gemtuzumab ozogamicin (Mylotarg, Pfizer) may be returning to the market in the United States after receiving a thumbs up from the Food and Drug Administration's (FDA's) Oncologic Drugs Advisory Committee (ODAC).

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FDA Panel Considers Leukemia Gene-Therapy Treatment

(Wall Street Journal) July 12, 2017 - A group of cancer experts started weighing Wednesday whether to recommend U.S. regulatory approval for a first-of-its kind gene therapy targeting an aggressive form of leukemia that occurs in children and young adults.

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New Approach to Leukaemia Can Help Improve Successful Treatment

(University of Liverpool [UK]) July 12, 2017 - New University research, presented at an international conference, confirms that a novel approach to the treatment of chronic myeloid leukaemia (CML) can safely increase treatment success and reduce negative side effects.

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ArQule Announces First Patient Dosed in Phase 1 Trial of BTK Inhibitor, ARQ 531, for B-cell Malignancies

(ArQule) July 11, 2017 - ArQule, Inc. today announced that the first patient has been dosed in a phase 1a/b trial with its BTK inhibitor, ARQ 531, in patients with B-cell malignancies refractory to other approved therapies.

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A Stem Cell Transplant Helped Beat Back A Young Doctor’s Cancer. Now, It’s Assaulting His Body

(Science Magazine) July 12, 2017 - A few months before completing medical school in 2003, Lukas Wartman was diagnosed with acute lymphoblastic leukemia (ALL), a blood cancer that's particularly lethal when it strikes adults. So began a battle to stay alive that has involved more than 70 drugs, two rounds of cell transplants, and a staggering series of twists and turns.

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