The AMS Blog

David L. Porter A higher dose of anti-CD19 chimeric antigen receptor T cells may lead to more complete responses among patients with relapsed or refractory chronic lymphocytic leukemia, according to results of a dose-optimization study published in Journal of Clinical Oncology. Although there was no statistically significant difference in OS between dose groups, patients who received a higher dose of CAR T-cells and achieved complete response to therapy achieved longer OS and PFS with manageable toxicity.  This group of researchers had…

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Last September, Johnson & Johnson said prostate cancer med Erleada had “barely missed” showing it could extend the lives of patients with nonmetastatic castration-resistant disease. But it’s now crossed that threshold. A combination of Erleada (apalutamide) and androgen deprivation therapy (ADT) slashed patients’ risk of death by 22% compared with a combination of ADT plus placebo, J&J said ahead of the American Society of Clinical Oncology virtual annual meeting.  RELATED: ESMO: J&J’s Erleada misses survival mark, but execs see reason to cheer…

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Last year, Medicare paid for $725 million worth of expensive medications administered in outpatient clinics — things like chemotherapy drugs — that ended up being discarded, according to new data released by the federal government. Why it matters: Although that amount is just 2% of what Medicare paid for those types of infusion drugs, that’s still a “very astonishing amount of waste,” said Rena Conti, a health economist at Boston University who has studied the issue. By the numbers: 10 highly discarded drugs accounted for…

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Dive Brief: Medtronic received De Novo authorization from FDA for a device designed to provide continuous dialysis therapy to critically ill small children, the agency disclosed Wednesday. The authorization will enable physicians to offer continuous renal replacement therapy (CRRT) to small pediatric patients without resorting to the off-label use of devices designed for larger children and adults. Medtronic plans to make the system, branded Carpediem, available through a “controlled market release” over the coming six months, a company spokesperson told MedTech Dive….

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A drug used to reduce severity of a common respiratory illness among infants is denied a quarter of the time by commercial insurers even if patients qualify for its recommended use, according to a new analysis.  Respiratory syncytial virus, or RSV, contributes to about 57,000 hospitalizations among children younger than five each year in the U.S. Virtually all children will get the infection before they are two and most of the time the symptoms are mild but in severe cases…

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Using brain MRI and a deep learning network, researchers have achieved 97% accuracy at classifying a gene mutation indicative of growth in localized gliomas.  If the science translates to the clinic, it may save many patients from having to undergo brain surgery for tumor biopsy.  A study describing the research, conducted at UT Southwestern Medical Center in Dallas, is running in the spring edition of Neuro-Oncology. The gene at the heart of the investigation, isocitrate dehydrogenase (IDH), has emerged as an important prognostic…

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Novartis is looking to grow its new multiple sclerosis drug Mayzent in a crowded field, and, with Gilenya generics threatening, the newer MS medicine may need to carry even more weight. It just racked up some new data that could help. New long-term data for Mayzent released Tuesday showed early treatment helped stave off disease progression in patients with secondary progressive MS (SPMS). The five-year open-label study extension, dubbed Expand, tracked the oral MS drug in two groups of SPMS patients—those who had been on the drug at…

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Bristol Myers Squibb and Exelixis have a potential kidney cancer contender on their hands—but they’ll have to meet a “high bar” to gain traction in the crowded field, one analyst says. A combination of Bristol’s immuno-oncology star Opdivo and Exelixis’ Cabometyx showed in a phase 3 trial that it could bestPfizer’s Sutent at staving off disease progression in previously untreated renal cell carcinoma patients. The pairing also hit the trial’s secondary endpoints, boosting the proportion of patients who responded to therapy…

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Dogged by whistleblower kickback claims over its multiple sclerosis med Gilenya for years, Novartis has run off a recent string of court wins to escape the allegations. But in one New Jersey suit, Novartis will now be forced to confront a former employee’s claims that he was fired without cause for bringing a kickback scheme to light. Novartis must face claims it retaliated against one of its employees for raising concerns the drugmaker engaged in a pharmacy benefit manager (PBM) kickback scheme for Gilenya,…

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When it comes to AstraZeneca blockbuster Tagrisso, Wolfe Research analyst Tim Anderson laid things out simply in a Friday note to clients: “A major new commercial opportunity just opened up.” At the recommendation of an Independent Data Monitoring Committee, the drugmaker will unblind a phase 3 trial of Tagrisso in postsurgery patients with EGFR-mutated non-small cell lung cancer two years ahead of schedule after the drug posted a significant benefit. “This is a major win for AstraZeneca,” Anderson wrote. The hot-selling pill…

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