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

Aptevo Therapeutics Doses First Patient in Phase 1/1b Clinical Trial of Lead Next-Generation Bispecific Antibody APVO436

(MarketWatch) Dec 13, 2018 - Aptevo Therapeutics Inc. announced today that the first patient has been dosed in a Phase 1/1b clinical trial of APVO436, a novel anti-CD123 by anti-CD3 bispecific antibody based on Aptevo’s ADAPTIR™ technology, which is being developed for the treatment of patients with Acute Myeloid Leukemia (AML) and High-Grade Myelodysplastic Syndrome (MDS).

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NCCN Updates Guideline for AML Treatment Induction, Post-Remission Therapy

(Journal of Clinical Pathways) Dec 13, 2018 - The National Comprehensive Cancer Network (NCCN) issued new guideline updates for older patients (aged at least 60 years) with acute myeloid leukemia (AML).

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Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

(MarketWatch) Dec 10, 2018 - Astellas Pharma Inc. today announced that XOSPATA® (generic name: gilteritinib) is now available for prescription in the United States for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

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Potential Seen For Tailoring Treatment For Acute Myeloid Leukemia

(UW School of Medicine) Dec 5, 2018 - Advances in rapid screening of leukemia cells for drug susceptibility and resistance are bringing scientists closer to patient-tailored treatment for acute myeloid leukemia (AML).

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XOSPATA® (gilteritinib) Available at Biologics by McKesson

(McKesson) Dec 7, 2018 - Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, announced that it has been selected by Astellas Pharma US Inc. to be in the limited distribution network for XOSPATA® (gilteritinib).

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3 Questions Leaving ASH

(BioPharma Dive) Dec 5, 2018 - Like many a medical meeting, ASH showcased data that — while promising — also offers as many questions as answers. With another American Society of Hematology meeting in the books, the industry can take a minute to appreciate the notable advances seen in San Diego earlier this week. A new collection of medicines look ready to take on multiple myeloma, while CAR-T and gene therapies affirmed their emerging place in the treatment of blood illnesses.

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At ASH, Bispecific Cancer Therapies Make A Mark

(BioPharma Dive) Dec 5, 2018 - In drugmakers' quest to coax immune cells to attack cancer, two might turn out to be better than one. Recent advances in cancer therapeutics have centered on the might of the body's defenders to recognize and kill tumor cells. Seeking to help the immune system "see" cancers, researchers have turned to treatments like checkpoint inhibitors and CAR-T cell therapy. At this year's annual meeting of the American Society of Hematology, however, another approach has shown promise in recruiting the immune system against lymphoma and multiple myeloma.

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Stemline Therapeutics Recaps Key Clinical Data Presentations from the American Society of Hematology (ASH) Annual Meeting

(Morningstar) Dec 6, 2018 - Stemline Therapeutics, Inc. presented updated data from multiple ELZONRISTM (tagraxofusp; SL-401) clinical trials at the 2018 ASH Annual Meeting.

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iCell Gene Therapeutics Presents First-in-Human Data of CLL1-CD33 Compound CAR T in Refractory Acute Myeloid Leukemia

(BioSpace) Dec 6, 2018 - iCell Gene Therapeutics, LLC announced results from a study ongoing at Chengdu Military General Hospital of ICG144, the first CLL1-CD33 Compound CAR T-cell (cCAR) in clinical study, in patients with particularly difficult to treat Acute Myeloid Leukemia (AML).

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The Future Of Cancer Care: A 50 Minute Discussion At Forbes

(Forbes) Dec 5, 2018 - During last Thursday’s Forbes Healthcare Summit, the final panel was entitled “Can We Cure Cancer,” and presented a unique view of the future of cancer therapy.

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Xencor Presents Initial Data from Phase 1 Study of XmAb®14045 in Acute Myeloid Leukemia at the 2018 ASH Annual Meeting

(Seeking Alpha) Dec 3, 2018 - Xencor, Inc., a clinical-stage biopharmaceutical company developing monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic diseases, and cancer, today announced initial data from its ongoing Phase 1 dose-escalation study of XmAb®14045, a CD123 x CD3 bispecific antibody, in patients with relapsed/refractory acute myeloid leukemia (AML).

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Late-Breaking Clinical Trials Advance Targeted Therapies for Patients with CLL and Multiple Myeloma

(ASH) Dec 4, 2018 - Three studies being presented today during the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego offer more targeted solutions for managing CLL and multiple myeloma. “The most important take home point is that all three of these late-breaking studies demonstrate how targeted therapies are improving outcomes for our patients,” said press briefing moderator Aaron Gerds, MD, MS, of the Cleveland Clinic Taussig Cancer Institute. “For both multiple myeloma and chronic lymphocytic leukemia, we’re rapidly shifting from cytotoxic to targeted treatments, which is exciting given the toxicities patients can experience with traditional chemotherapy.”

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Ibrutinib Plus Rituximab Superior To Standard Treatment For Some Patients With Chronic Leukemia

(NCI) Dec 4, 2018 - An interim analysis of a large phase 3 clinical trial found that the combination of ibrutinib plus rituximab was superior to standard treatment for patients age 70 and younger with previously untreated chronic lymphocytic leukemia (CLL). The trial met its primary endpoint of an improvement in progression-free survival (the length of time patients live before their disease worsens). The combination also improved overall survival, the trial’s secondary endpoint. In general, patients in the ibrutinib–rituximab arm were less likely to experience serious side effects than those in the standard treatment arm. Until now, the standard treatment for previously untreated CLL has been a six-month course of FCR, which combines the chemotherapy drugs fludarabine and cyclophosphamide with rituximab.

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New Phase 3 Study Findings Show IMBRUVICA® (ibrutinib) Plus Rituximab Significantly Improved Survival Compared to Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Previously Untreated Patients Aged 70 or Younger with Chronic Lymphocytic Leukemia

(J&J) Dec 4, 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the National Cancer Institute (NCI)-sponsored Phase 3 study (E1912) led by the ECOG-ACRIN Research Group (ECOG-ACRIN) evaluating IMBRUVICA® (ibrutinib) plus rituximab compared to a chemotherapy regimen of fludarabine, cyclophosphamide, and rituximab (FCR) in previously untreated patients aged 70 years or younger with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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IMBRUVICA® (ibrutinib) Plus Obinutuzumab Showed Significant Improvement in Progression-Free Survival Compared to Chlorambucil Plus Obinutuzumab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

(J&J) Dec 3, 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 3 iLLUMINATE (PCYC-1130) study, which showed the combination of IMBRUVICA® (ibrutinib) plus obinutuzumab significantly improved progression-free survival (PFS) versus chlorambucil plus obinutuzumab in patients with newly diagnosed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the most common form of leukemia in adults.

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New Venclexta/Venclyxto Data Demonstrate Deep Responses In Two Of The Most Common Types Of Leukaemia

(Roche) Dec 4, 2018 - Roche today announced new data from the Venclexta®/Venclyxto® (venetoclax) clinical development programme, including longer-term results from the phase III MURANO study in people with previously treated chronic lymphocytic leukaemia (CLL) and updated data from two phase Ib/II studies in people with previously untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy due to coexisting medical conditions.

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Amgen Announces First-In-Human Data Evaluating Investigational Novel BiTE® Immunotherapies AMG 420 And AMG 330 At ASH 2018

(Amgen) Dec 3, 2018 - Phase 1 results of Amgen's BiTE® platform in heavily pre-treated patients with multiple myeloma and acute myeloid leukemia; FDA grants Fast Track Designation for AMG 420.

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Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

(Gilead) Dec 3, 2018 - Kite, a Gilead Company, announced updated results from ZUMA-3, a single-arm Phase 1/2 study evaluating KTE-X19 (formerly KTE-C19), an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy, in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

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Allogene Therapeutics and Servier Present Pooled Data from Phase 1 Trials of Allogeneic UCART19 in Relapsed/Refractory Acute Lymphoblastic Leukemia

(Yahoo! Finance) Dec 3, 2018 - Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, and Servier, an independent international pharmaceutical company, today announced results from an updated analysis of pooled clinical data from two ongoing Phase 1 studies of UCART19, the first allogeneic CAR T-cell therapy in clinical study, in pediatric (PALL) and adult (CALM) patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).

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Celyad Presents Update on CYAD-01 Hematological Malignancies Clinical Program at 60th ASH Annual Meeting

(Celyad) Dec 4, 2018 - Celyad, a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today announced updated clinical data for the CYAD-01 program in hematological malignancies presented at the American Society of Hematology (ASH) 60th Annual Meeting.

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