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

U.S. FDA Approves INREBIC® (Fedratinib) as First New Treatment in Nearly a Decade for Patients With Myelofibrosis

(Celgene) Aug 16, 2019 - Celgene Corporation today announced the U.S. Food and Drug Administration (FDA) has approved INREBIC® (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. “The approval of INREBIC is another important milestone for Celgene and underscores our commitment to people living with blood cancers,” said Jay Backstrom, M.D., M.P.H., Chief Medical Officer for Celgene. “We are excited to provide INREBIC as a new treatment option that may be used in patients with myelofibrosis, including patients previously treated with ruxolitinib.”

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Calquence Granted US Breakthrough Therapy Designation For Chronic Lymphocytic Leukaemia

(AstraZeneca) Aug 14, 2019 - AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults. José Baselga, Executive Vice President, Oncology R&D, said: “This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease. The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports Calquence as a highly-selective Bruton tyrosine kinase inhibitor with the potential to offer patients a new, differentiated, chemotherapy-free treatment option with a favourable safety profile.”

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AZ' Calquence Granted US Breakthrough Therapy Designation

(PharmaTimes [UK]) Aug 14, 2019 - AstraZeneca has announced that Calquence (acalabrutinib) has been granted US Breakthrough Therapy Designation (BTD) for chronic lymphocytic leukaemia. The US Food and Drug Administration (FDA) granted the designation as a monotherapy treatment for adult patients with the disease, based on positive results from the interim analyses of the ELEVATE-TN and ASCEND Phase III clinical trials, which will serve as the foundation for regulatory submissions later this year.

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UChicago Medicine Oncologist To Receive Prestigious Medal For Leukemia Research

(UChicago Medicine) Aug 13, 2019 - For his pioneering hematology research, University of Chicago Medicine oncologist and professor Richard A. Larson, MD, will receive the 2019 Henry M. Stratton Medal from the American Society of Hematology.

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Janssen Announces European Commission Approval of Imbruvica® (ibrutinib) for Expanded Use in Two Indications

(Yahoo! Finance) Aug 13, 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has approved variations to broaden the use of Imbruvica® (ibrutinib) in two indications.

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Onconova Therapeutics and Mission Bio Partner to Advance Precision Oncology Clinical Trials Employing Single-Cell Genomics

(Onconova) Aug 12, 2019 - The alliance will leverage Mission Bio’s Tapestri Platform to investigate Onconova’s novel cancer therapy rigosertib, through clinical trials.

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CMS Finalizes Long-Sought Rules For Medicare CAR-T Coverage

(STAT) Aug 7, 2019 - The Trump administration finalized late Wednesday long-sought rules for when Medicare will cover CAR-T treatments, the cutting-edge, often curative therapies that harness patients’ own immune cells against their cancer. Under the new policy, Medicare will pay for CAR-T therapies so long as they’re administered in health care facilities that follow the Food and Drug Administration’s special safety rules, known as risk evaluation and mitigation strategies, or REMS. Medicare will also pay for CAR-T even when it’s used to treat conditions that aren’t FDA-approved. The two CAR-T treatments on the market, Gilead’s Yescarta and Novartis’ Kymriah, are approved to treat non-Hodgkin lymphoma and acute lymphoblastic leukemia, respectively.

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Medicare Will Cover Pioneering Cancer Treatment Nationwide

(Washington Post) Aug 7, 2019 - Medicare announced it would cover CAR T-cell therapy, an innovative but expensive treatment for blood cancers, nationwide. Previously, the program's regional administrators decided whether to cover the therapy. Medicare will cover an innovative but high-priced cancer treatment nationwide, a step Trump administration officials said Wednesday would ensure patients have “consistent and predictable access” to a potentially lifesaving therapy.

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Combination Targeted Therapy May Offer Hope To Infants With A Deadly Type Of Leukemia

(City of Hope) Aug 7, 2019 - City of Hope researchers have identified a potential combination targeted therapy for a deadly type of leukemia found in some infants, a population too young to receive full-blown chemotherapy.

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Geron Starts Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes

(Geron) Aug 8, 2019 - Geron Corporation today announced the opening of patient screening and enrollment for the Phase 3 portion of IMerge to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS).

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Oncternal Therapeutics Announces Opening of Randomized Phase 2 Study of Cirmtuzumab in Combination with Ibrutinib

(NASDAQ) Aug 6, 2019 - Interim objective response rate of 100% in evaluable patients with CLL receiving the recommended dosing regimen supports opening Phase 2.

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Medicare Boosts Payment For Breakthrough Cancer Therapy

(Washington Post) Aug 2, 2019 - Medicare officials on Friday said it would increase reimbursements to hospitals for expensive new medical technologies, including a high-priced therapy used as a last-resort treatment for patients with blood cancers. The Centers for Medicare and Medicaid Services issued a final rule raising payments for new technologies from 50 percent to 65 percent of estimated costs. CMS Administrator Seema Verma said the step would promote access to potentially lifesaving treatments and reduce uncertainty about payments for a cancer immunotherapy known as CAR T-cell therapy, among other new therapies.

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$2,733 To Treat Iron-Poor Blood? Iron Infusions For Anemia Under Scrutiny

(NPR/Kaiser Health News) Aug 1, 2019 - Iron-deficiency anemia is often remedied with drugstore iron pills. But if that doesn't work, doctors sometimes prescribe iron infusions — and the bill for that can vary by thousands of dollars. Why? Shannon Wood Rothenberg walked into her annual physical feeling fine. But more than a year later, she's still paying the price.

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Drug Combo Heralds Major Shift In Chronic Lymphocytic Leukemia Treatment

(Stanford Medicine) July 31, 2019 - A combination of two drugs keeps patients with chronic lymphocytic leukemia disease-free and alive longer than the current standard of care, according to a phase-3 clinical trial of more than 500 participants conducted at the Stanford University School of Medicine and multiple other institutions. The results of the trial are likely to change how most people with the common blood cancer are treated in the future, the researchers believe.

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Chimerix Announces Exclusive Worldwide License of Phase 3 Ready CX-01 for Development in Acute Myeloid Leukemia

(Markets Insider) July 31, 2019 - Chimerix, today announced the completion of an exclusive worldwide license of CX-01 from Cantex Pharmaceuticals, Inc. Chimerix intends to move quickly into Phase 3 development of CX-01 for the treatment of Acute Myeloid Leukemia (AML) in the first-line setting.

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Researchers Discover New Combination Therapy to Treat Drug-Resistant Acute Lymphoblastic Leukemia

(CWRU) July 29, 2019 - Acute lymphoblastic leukemia accounts for one in five adult leukemias, and is the most common pediatric cancer in the United States.

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How Scientists Built A ‘Living Drug’ To Beat Cancer

(Wired) July 25, 2019 - In 2010, EMILY Whitehead was diagnosed with Acute Lymphoblastic Leukemia, a cancer of certain cells in the immune system.

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FDA Approves Pfizer's Rituximab Biosimilar, Ruxience

(The Center For Biosimilars) July 23, 2019 - The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. “Biosimilars like Ruxience have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care,” said Andy Schmeltz, global president of Pfizer Oncology, in a statement. “The FDA approval marks our third oncology biosimilar to be approved in the US this year, reinforcing our commitment to bring these important medicines to patients living with cancer.”

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FDA Approves Pfizer’s Biosimilar, RUXIENCE™ (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions

(Pfizer) July 23, 2019 - Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). “Biosimilars like RUXIENCE have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care,” said Andy Schmeltz, Global President, Pfizer Oncology. “The FDA approval marks our third oncology biosimilar to be approved in the U.S. this year, reinforcing our commitment to bring these important medicines to patients living with cancer.”

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Trillium Therapeutics Provides Corporate Update

(Trillium) July 24, 2019 - FDA meeting scheduled to discuss the pivotal path for intratumoral TTI-621 in CTCL.

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