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Featured Oncology News

FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of FL, DLBCL and CLL

(ASCO in Action) June 22, 2017 - On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (RITUXAN HYCELA, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

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FDA Approves Dabrafenib and Trametinib Combination for Metastatic NSCLC with BRAF V600E Mutation

(ASCO in Action) June 22, 2017 - On June 22, 2017, the U.S. Food and Drug Administration granted regular approvals to dabrafenib and trametinib (TAFINLAR® and MEKINIST®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. These are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.

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The Closest Thing To A Shoo-In Pfizer Has Ever Handed To The FDA Just Got Rejected

(Endpoints News) June 22, 2017 - This is the second CRL for the biosimilar.

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Oncology Clinical News

Novartis Pivotal CTL019 6-month Follow-Up Data Show Durable Remission Rates In Children, Young Adults With R/R B-cell ALL

(Novartis) June 23, 2017 - Novartis today announced updated results from the ELIANA clinical trial demonstrating CTL019 (tisagenlecleucel) remission rates are maintained at six months in relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).

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Roche Presents New Data From GALLIUM Study Reinforcing Clinical Benefit of Gazyva/Gazyvaro in People With Previously Untreated Follicular Lymphoma

(Roche) June 23, 2017 - Roche announced today that new data from additional analyses of the pivotal phase III GALLIUM study in people with previously untreated follicular lymphoma will be presented at the 22nd European Hematology Association (EHA) annual congress, 22-25 June, in Madrid, Spain.

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Presentation Confirms Venclexta/Venclyxto Monotherapy Benefit in Certain Patients With High-Risk Chronic Lymphocytic Leukaemia and its Potential in Other Hard-to-Treat Blood Cancers

(Roche) June 23, 2017 - Roche today announced new data from multiple studies of Venclexta®/Venclyxto® (venetoclax), presented at the 22nd European Hematology Association (EHA) Annual Congress, 22-25 June, in Madrid. Data presented in relapsed or refractory chronic lymphocytic leukaemia (CLL) confirmed the efficacy of Venclexta/Venclyxto with high and durable response rates and a well-tolerated safety profile in this high-risk population, including people with 17p chromosomal deletion who had previously received treatment.

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Novartis Announces Half of Eligible Ph+ CML-CP Patients Remain in Treatment-free Remission (TFR) Nearly Two Years After Stopping Tasigna® (nilotinib)

(Yahoo! Finance) June 23, 2017 - Novartis today announced new data from two clinical trials, ENESTfreedom and ENESTop, which demonstrate that approximately half of adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase (CP), were able to maintain TFR after stopping treatment with Tasigna (nilotinib) both in the first-line setting and after switching from Glivec (imatinib)

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NEJM Publishes Full Analysis of Rydapt® (midostaurin) Phase III RATIFY Trial In Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML)

(Novartis) June 23, 2017 - Novartis today announced that full results from the Rydapt [®] (midostaurin) Phase III RATIFY (CALGB 10603 [Alliance]) clinical trial were published in The New England Journal of Medicine (NEJM).

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Karyopharm Reports Updated Phase 2b SADAL Data for Selinexor in Diffuse Large B-Cell Lymphoma at the 2017 European Hematology Association Annual Meeting

(Morningstar) June 23, 2017 - Karyopharm Therapeutics Inc. today reported updated clinical data from the ongoing Phase 2b Selinexor Against Diffuse Aggressive Lymphoma (SADAL) study evaluating lead product candidate, selinexor (KPT-330), an oral Selective Inhibitor of Nuclear Export / SINE™ compound, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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Positive Phase 1b Data for NewLink Genetics’ IDO Pathway Inhibitor, Indoximod, in Combination with Chemotherapy for Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Presented at the European Hematologic Association (EHA) Congress in Madrid, Spain

(Morningstar) June 23, 2017 - NewLink Genetics Corporation today announced the presentation of data from the Phase 1b portion of a study of indoximod, an IDO pathway inhibitor, in combination with idarubicin and cytarabine for patients with newly diagnosed acute myeloid leukemia (AML).

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Bellicum Reports Clinical Results of BPX-501 in Pediatric Leukemias at the 22nd Congress of the European Hematology Association

(Morningstar) June 23, 2017 - Oral presentation highlights high success rate of haploidentical transplants, with low incidence of disease relapse and uncontrolled GvHD.

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Takeda Pharmaceutical: Presents Data from Phase 1/2 Studies for NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma Patients and in the Maintenance Setting

(4-traders) June 23, 2017 - Early studies of weekly and twice-weekly ixazomib plus lenalidomide and dexamethasone demonstrate deep responses after induction, with deepening responses seen after single-agent ixazomib maintenance; Data to be presented during two oral sessions at the 2017 European Hematology Association (EHA) Annual Meeting.

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Cleveland Clinic Researchers Discover Similarities Between Next-Generation Prostate Cancer Drugs

(Cleveland Clinic) June 22, 2017 - Cleveland Clinic researchers have shown for the first time how a class of advanced prostate cancer drugs are processed in the body and how their anti-tumor activity might change depending on how they are metabolized.

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Existing Drugs Could Benefit Patients With Bone Cancer, Genetic Study Suggests

(Wellcome Trust Sanger Institute [UK]) June 23, 2017 - A subgroup of patients with osteosarcoma – a form of bone cancer – could be helped by an existing drug, suggest scientists from the Wellcome Trust Sanger Institute and their collaborators at University College London Cancer Institute and the Royal National Orthopaedic Hospital NHS Trust.

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RadioMedix Inc. and AREVA Med Announce Completion of the Exploratory Clinical Trial of 203Pb-AR-RMX in Patients Expressing Somatostatin Receptor Positive Neuroendocrine Tumors

(RadioMedix) June 21, 2017 - RadioMedix Inc and AREVA Med announced today the completion of the exploratory clinical trial evaluating the biodistribution and safety of 203Pb-AR-RMX in patients with somatostatin receptor positive neuroendocrine tumors in May of 2017.

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Oncology Business and Policy News

FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies

(Morningstar) June 22, 2017 - The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing (NGS)-based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC).

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U.S. Physicians Move to More Flexible Mammogram Schedule

(Reuters Health) June 22, 2017 - Women at average risk for breast cancer should be offered screening mammograms every year or two starting at age 40 and they should start regular screening no later than age 50, an influential U.S. group of obstetricians and gynecologists said on Thursday.

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Novartis Breast Cancer Drug Kisqali Wins European Panel Backing

(Reuters) June 23, 2017 - A European Medicines Agency (EMA) panel recommended on Friday approving Novartis's Kisqali drug, bolstering the Swiss drugmaker's bid to challenge rival Pfizer's Ibrance against tough-to-treat breast cancer.

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Cambridge’s Aveo Eyes Turnaround As Cancer Drug Nears E.U. Nod

(Boston Business Journal) June 23, 2017 - Aveo said Friday that European regulators are expected to reach a decision on tivozanib in about two months.

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Bayer: Receives Positive CHMP Opinion for regorafenib for the Second-Line Systemic Treatment of Liver Cancer

(4-traders) June 23, 2017 - Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended regorafenib for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar®(sorafenib).

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ASCO Opposes Senate Healthcare Bill, Urges Lawmakers to Reject Measure

(ASCO in Action) June 22, 2017 - Statement by Bruce E. Johnson, MD, FASCO, President of the American Society of Clinical Oncology (ASCO).

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Opinion: Get Cancer Now, Before Congress Cuts Your Insurance

(New York Times) June 23, 2017 - After 16 years working in the health insurance lottery, I know what’s at stake.

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First Opinion: In Defense Of Medicare’s Annual Wellness Exam

(STAT) June 23, 2017 - In my work as a primary care physician, time is a precious commodity. I rarely have enough of it in office visits with my patients. That’s one reason I’m all in favor of Medicare’s free annual wellness visits, though I know that other physicians feel differently about them.

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Making Sense of Breast Cancer, Health Insurance and Time Off Work

(U.S. News & World Report/HealthDay News) June 22, 2017 — Balancing work, treatment and recovery can be challenging for some patients.

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Georgia State Hosts First International Triple Negative Breast Cancer Conference

(Georgia State University) June 22, 2017 - Georgia State University will host the First International Triple Negative Breast Cancer Conference from Sept. 18 to 20.

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University of Kansas School of Medicine Names Weijing Sun Medical Oncology Division Director

(KU Medical Center) June 22, 2017 - The University of Kansas School of Medicine and The University of Kansas Cancer Center have appointed Weijing Sun, M.D., the new Sprint Foundation Professor of Medical Oncology and the director of the Division of Medical Oncology. He also will be associate director for clinical research for the KU Cancer Center.

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New Ethical Lapses Alleged in Controversial India Cervical Cancer Screening Trial

(STAT) June 23, 2017 - A long-debated study aimed at validating a low-cost way to screen for cervical cancer in India has come under fire again, based on new evidence of ethical lapses contained in documents obtained through the U.S. Freedom of Information Act.

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Broader Healthcare and Pharma News

Promises Made To Protect Preexisting Conditions Prove Hollow

(Kaiser Health News) Updated June 23, 2017 - Senate Republicans praised the Affordable Care Act replacement bill they presented Thursday as preserving coverage for people with cancer, mental illness and other chronic illness.

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Editorial: The Senate’s Unaffordable Care Act

(New York Times) June 23, 2017 - The bill’s real aim is to cut taxes for the rich at the expense of health services that millions depend on.

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Bluebird Bio’s Gene Therapy For Blood Disorders Yields Some Impressive Results ― But Also Raises Questions

(STAT) June 23, 2017 - Bluebird is testing a gene therapy for two inherited blood disorders ― and the data managed both to impress and to leave important questions unanswered.

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Samsung Makes Play for Drug Market With Version of Humira

(FOXBusiness/Dow Jones Newswires) June 23, 2017 - A Samsung group arm is on track to win European regulatory approval for a near-replica version of the world's top-selling drug, AbbVie Inc.'s rheumatoid-arthritis treatment Humira, the latest achievement by the deep-pocketed South Korean conglomerate attempting to shake up the pharmaceutical market.

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Pharma’s New Justification For High Drug Prices, And Other Takeaways from #BI02017

(STAT Plus) June 23, 2017 - Here are our takeaways from four days of talking and listening to executives here:

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