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Featured Oncology News

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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FDA Approves Third Oncology Drug That Targets A Key Genetic Driver Of Cancer, Rather Than A Specific Type Of Tumor

(FDA.gov) Aug 15, 2019 - The U.S. Food and Drug Administration today granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. “We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine,” said FDA Acting Commissioner Ned Sharpless, M.D.

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Oncology Clinical News

First Clinical Trial of Drug-Inducible Gene Therapy Yields Encouraging Preliminary Results

(Brigham and Women’s Hospital) Aug 14, 2019 - A new clinical trial by investigators from Brigham and Women’s Hospital and Dana-Farber Cancer Institute set out to test the safety and effectiveness of controlling a powerful immunotherapy, known as human interleukin-12 (hIL-12), by using an oral activator — a drug that can give finer control over when a gene gets turned on — in patients with recurrent glioblastoma.

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Study: Non-invasive Electrical Stimulation Alters Blood Flow in Brain Tumors

(BIDMC) Aug 14, 2019 - In a first-of-its kind study, neurologists at Beth Israel Deaconess Medical Center (BIDMC) tested the use of non-invasive electrical stimulation as a novel therapeutic approach to brain tumors.

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Breast Cancer Gene Mutation Also Increases Risk Of Type Of Childhood Cancer

(Forbes) Aug 16, 2019 - New research from St Jude's children hospital in Memphis has also linked the presence of mutations in one of the genes; BRCA2 to an increased risk of a type of childhood lymphoma.

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Chemical Screening Suggests A Two-Pronged Treatment For Paediatric Ewing Sarcoma

(Boston Children’s Hospital) Aug 14, 2019 - For children with Ewing sarcoma, an aggressive bone cancer, a combination of two different classes of drugs may work synergistically to turn off the drivers fuelling this disease, finds a new study.

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Discovery Of How Cells Override Genetic Changes Could Lead To New Approaches In Pancreatic Cancer Treatment

(HCI) Aug 15, 2019 - A discovery by scientists at Huntsman Cancer Institute (HCI) at the University of Utah (U of U) could lead researchers to a more effective way to treat pancreatic cancer. Their findings were published today in Developmental Cell.

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Numbers Count In The Genetics Of Moles And Melanomas

(UQ [Brisbane, Australia]) Aug 16, 2019 - University of Queensland scientists have identified a way to help dermatologists determine a patient’s risk of developing melanoma.

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Oncology Business and Policy News

Is Roche Starting A Price War In Cancer? Maybe Not

(STAT Plus) Aug 16, 2019 - On Thursday night, Roche announced that it would price Rozlytrek, its newly approved pill to treat cancer related to specific, rare genetic alterations, at $17,050 a month, about half the cost of a competing drug, Vitrakvi, sold by Eli Lilly and Bayer.

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How Amgen Plans to BiTE into CAR-T’s Hype

(STAT Plus) Aug 16, 2019 - While personalized CAR-T cancer therapies make headlines in biotech, Amgen has been betting big on another tumor-killing approach with, yes, another acronym: BiTEs.

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Profound Medical Receives U.S. FDA 510(k) Clearance for TULSA-PRO®

(NASDAQ) Aug 16, 2019 - Profound Medical Corp. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market TULSA-PRO® for ablation of prostate tissue. TULSA-PRO® is a transurethral prostate tissue ablation system that combines real-time Magnetic Resonance Imaging ("MRI") with robotically-driven directional thermal ultrasound and closed-loop temperature feedback control software to deliver predictable physician prescribed ablation of whole-gland or partial prostate tissue. The TULSA-PRO® system is designed to provide customizable and predictable, incision-free and radiation-free prostate ablation while actively protecting the urethra and rectum with water cooling to preserve men's functional abilities.

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Nuclear Pharmacies Sue A Key Supplier Of Radiology Medicines For Pursuing An ‘Illegal Monopoly’

(STAT Plus) Aug 15, 2019 - The largest association of independent nuclear pharmacies in the U.S. has filed a lawsuit accusing Jubilant DraxImage, a big supplier of radiology medicines, with a range of anticompetitive practices that have resulted in dramatically higher prices that have allegedly hurt patient care.

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Study Finds Lack Of Racial Diversity In Cancer Drug Clinical Trials

(University of British Columbia [Canada]) Aug 16, 2019 - New research published this week in JAMA Oncology has found a lack of racial and ethnic diversity in clinical trials for cancer drugs.

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American Cancer Society Names Dr. William Cance Chief Medical and Scientific Officer

(ACS) Aug 15, 2019 - New position will lead integration of ACS’ research and cancer control program to aggressively pursue 2035 challenge goal to reduce cancer mortality by 40 percent.

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ASCO Announces CancerLinQ Discovery® Research Support Grant Recipients

(ASCO) Aug 15, 2019 - The American Society of Clinical Oncology (ASCO) announced today the three recipients of its CancerLinQ Discovery® Research Support Grant.

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ASCO Submits Comments on Proposed Changes that Could Impact Sexual and Gender Minorities with Cancer

(ASCO in Action) Aug 15, 2019 - Last week, ASCO submitted a comment letter to Alex M. Azar II, Secretary of Health and Human Services (HHS), regarding the proposed rule on Sec. 1557 of the Affordable Care Act (ACA)—Nondiscrimination in Health and Health Education Programs or Activities.

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Broader Healthcare and Pharma News

Trump Health Official: Controversial Drug Pricing Move Is 'Top Priority'

(The Hill) Aug 15, 2019 - A top Trump administration health official on Thursday indicated that the administration is pushing forward with a controversial proposal to lower drug prices, despite opposition from some fellow Republicans.

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Cases of Vaping-Linked Breathing Problems Now Reported In 8 States

(NBC News) Aug 15, 2019 - Doctors have not yet been able to pinpoint any specific device, brand or ingredient tying the cases together.

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Top U.S. Medical Centers Roll Out DNA Sequencing Clinics For Healthy (And Often Wealthy) Clients

(STAT) Aug 16, 2019 - Seizing on the surging popularity of at-home DNA testing kits, top academic medical institutions are opening clinics that promise to probe much deeper into your DNA — if you’re willing to pay hundreds or even thousands of dollars out of pocket to learn about disease risks that may be lurking in your genes.

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Gilead Eyes 2019 FDA Submission for Filgotinib

(MD Magazine) Aug 16, 2019 - The investigative Janus kinase (JAK1) inhibitor from Gilead Sciences has been accepted for marketing review by the European Medicines Agency (EMA) as a potential therapy for rheumatoid arthritis.

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‘Fraud in the Lab’ Review: Experiments in Doubt

(Wall Street Journal) Aug 14, 2019 - Lapses of rigor, misleading methods, outright falsification: How common are the transgressions of research scientists?

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