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U.S. Proposes Medicare Coverage For CAR-T Cancer Therapies

(Reuters) Feb 15, 2019 - The U.S. Centers for Medicare & Medicaid Services (CMS) on Friday proposed Medicare coverage of approved CAR-T cell therapies that use the patient’s immune system to fight cancer. The proposal would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment, CMS said. The evidence from these studies and registries would help the agency identify the patients that benefit from CAR-T cell therapies.

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FDA Grants Priority Review to Keytruda Combo as Frontline Treatment for Kidney Cancer

(Curetoday.com) Feb 15, 2019 - The Food and Drug Administration (FDA) granted a priority review to Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as a frontline treatment for advanced renal cell carcinoma (RCC), according to Merck, the manufacturer of the anti-PD-1 therapy. “Many patients with advanced renal cell carcinoma face a poor prognosis and there remains a need for new and effective treatment options in the first-line setting,” said Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories, in a press release. The new biologics license application was based on findings from the phase 3 KEYNOTE-426 trial, designed to evaluate Keytruda in combination with Inlyta compared with Sutent (sunitinib) as a frontline treatment in 861 patients with advanced RCC.

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Bayer/Orion Showcase Results From Prostate Cancer Challenger

(Pharmaphorum.com [UK]) Feb 15, 2019 - Bayer and development partner Orion have released detailed results from the trial that will form the backbone of its filing for their latest prostate cancer drug, as they aim to take on two established blockbusters from Johnson & Johnson and Pfizer/Astellas. J&J and Astellas market androgen receptor antagonists Zytiga (abiraterone) and Xtandi (enzalutamide) respectively – but Bayer hopes to take them on with a drug that may have a safety advantage if approved. Xtandi has been shown to cross the blood-brain barrier and has been linked with neurological side-effects, while evidence gathered so far shows that darolutamide does not penetrate the barrier.

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All Breast Cancer Patients Should Get Genetic Testing, Surgeons Say

(CNN) Feb 14, 2019 - Barriers to genetic testing need to fall as knowledge of inherited cancer risks grows, surgeons say. Genetic testing should be made available for all patients diagnosed with breast cancer, according to guidelines published Thursday by the American Society of Breast Surgeons. The professional medical society has more than 3,000 members in the United States and 35 countries throughout the world.

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Oncology Clinical News

Immunotherapy Combination Generates Responses Against Castration-Resistant Metastatic Prostate Cancer

(MD Anderson) Feb 14, 2019 - Some patients with metastatic prostate cancer respond to a combination of immune checkpoint inhibitors after hormonal therapy and chemotherapy have failed, according to early results from a clinical trial led by investigators at The University of Texas MD Anderson Cancer Center presented today at the the ASCO GU Symposium in San Francisco.

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Rainier Therapeutics Presents Data on Vofatamab in Patients with Advanced Urothelial Cell Carcinoma (Bladder Cancer) Previously Treated with Chemotherapy at ASCO GU 2019

(Rainier Therapeutics) Feb 15, 2019 - Preliminary data from FIERCE-21 Phase 2 trial highlighted in oral presentation supports advancement to pivotal study. Single agent activity and long-term treatment duration demonstrated.

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New Clinical Data Analysis Shows Survival Benefit Three Years after Treatment with Sipuleucel-T

(Associated Press) Feb 14, 2019 - Dendreon Pharmaceuticals LLC, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, released results of a new retrospective analysis of clinical trial data showing a long-lasting survival benefit three years after treatment with PROVENGE® (sipuleucel-T) in men with metastatic castrate-resistant prostate cancer (mCRPC). (abstract #222).

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Genetic Variations In A Fourth Gene Linked To Elevated Leukemia Risk In Hispanic Children

(St. Jude Children’s) Feb 14, 2019 - St. Jude Children’s Research Hospital scientists have completed one of the largest studies yet designed to advance understanding of why Hispanic children are more likely to develop leukemia and less likely to survive.

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E-cigarette Users Show Cancer-Linked Genetic Changes

(USC News) Feb 14, 2019 - A USC study in 93 people shows that e-cigarette users develop some of the same cancer-related molecular changes in oral tissue as cigarette smokers, adding to the growing concern that e-cigarettes aren’t a harmless alternative to smoking.

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Mammography and CT Lung Cancer Screening Can Improve Population-Based Health Outcomes

(UCSF) Feb 14, 2019 - Recent studies have supported a recommendation by the UC San Francisco Department of Radiology and Biomedical Imaging that annual mammography screening start at age 40 for women of low or average risk. But mammography can also lead to another health benefit—an opportunity for women to receive lung cancer screening (and smoking cessation counseling), if eligible.

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Artificial Intelligence Can Predict Survival Of Ovarian Cancer Patients

(Imperial College London [UK]) Feb 15, 2019 - Researchers have created new machine learning software that can forecast the survival rates and response to treatments of patients with ovarian cancer.

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Oncology Business and Policy News

Lilly Completes Acquisition of Loxo Oncology

(Benzinga) Feb 15, 2019 - Eli Lilly and Company today announced the successful completion of its acquisition of Loxo Oncology, Inc.

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Bayer to Obtain Full Rights To Global Development And Commercialization Of Oncology Compounds Vitrakvi® (larotrectinib) and BAY 2731954 (LOXO-195)

(Morningstar) Feb 15, 2019 - Bayer to be solely responsible for the global development and commercialization of both Vitrakvi® and BAY 2731954 (LOXO-195). Co-promotion of Vitrakvi® in the U.S. to be converted into exclusive commercialization by Bayer.

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AZ Says Dropping Medimmune Will Help ‘Streamline’ its R&D

(PMLiVE [UK]) Feb 15, 2019 - The demise of the MedImmune brand, which has driven AstraZeneca’s biologics pipeline for more than a decade, will strengthen the group’s R&D and make it more agile, say executives.

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Breast-Density Notification Letters May Be Too Dense

(Reuters Health) Feb 14, 2019 - Post-mammogram form letters telling women about dense breasts may be more confusing than helpful if they are difficult to read and understand, researchers say. Thirty U.S. states require providers to send letters to patients explaining that so-called dense breasts - which have more breast tissue and less fat - make mammograms harder to read, which increases chances that a cancer could be missed. Having dense breasts also raises the risk of developing breast cancer, the study team notes in Journal of the American College of Radiology.

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FDA Observes Manipulation of Data at Immunomedics Facility

(BioPharma-Reporter.com [UK]) Feb 14, 2019 - Following the US FDA issuing a CRL to Immunomedics, the agency has revealed its inspection found instances of data integrity breaches and manipulation.

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NICE Changes Its Mind on Perjeta

(PharmaTimes [UK]) Feb 15, 2019 - NICE has changed its mind and recommended Roche’s Perjeta for a new breast cancer indication.

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Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response

(MarketWatch) Feb 14, 2019 - Bio-Rad’s system and kit can precisely and reproducibly monitor molecular response to treatment in patients with chronic myeloid leukemia (CML).

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ASCO Weighs-In on Widespread Youth Tobacco Use; See the Latest National Youth Tobacco Survey Results

(ASCO in Action) Feb 14, 2019 - Approximately 5 million middle and high school students reported currently using a tobacco product, with over 3.6 million currently using e-cigarettes and about half (2.5 million) currently using a combustible tobacco product, according to the latest findings from the National Youth Tobacco Survey (NYTS).

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Life After Cancer: More Survivors Living Longer, Facing New Health Challenges

(USA Today) Feb 13, 2019 - More cancer patients are living longer. Few are getting the help they need to stay healthy.

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Broader Healthcare and Pharma News

Draft Federal Spending Deal Includes Largest Boost For FDA In Five Years

(STAT Plus) Feb 14, 2019 - A government funding deal released late Wednesday includes $269 million in new funding for the Food and Drug Administration, which would represent the largest increase the agency has seen in at least five years.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on New Policy To Improve Access And Foster Price Competition For Drugs That Face Inadequate Generic Competition

(FDA.gov) Feb 15, 2019 - In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients.

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UN: Experts to Develop Oversight Standards For Gene Editing

(Associated Press) Feb 14, 2019 - In a statement Thursday, the World Health Organization announced it had chosen an expert panel to examine the scientific, ethical, social and legal challenges linked to gene editing.

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The Instant, Custom, Connected Future of Medical Devices

(New York Times) Feb 14, 2019 - 3D-printed and “smart” pharmaceuticals are making medical treatments more effective. But it may take years before the new devices reach most patients, if they do at all.

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