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(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.
read article(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.
read article(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.
read article(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.
read article(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.
read press release(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.
read corporate press release(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).
read article(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.
read press release(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.
read article(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.
read article(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.
read article(Benzinga) Feb 15, 2019 - Eli Lilly and Company today announced the successful completion of its acquisition of Loxo Oncology, Inc.
read article(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.
read article(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.
read article(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.
read article(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.
read article(PharmaTimes [UK]) Feb 15, 2019 - NICE has changed its mind and recommended Roche’s Perjeta for a new breast cancer indication.
read article(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).
read article(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).
read article(USA Today) Feb 13, 2019 - More cancer patients are living longer. Few are getting the help they need to stay healthy.
read article(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.
read article (paid subscription required)(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.
read press release(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.
read article(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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