New Drugs

  • FDA approves midostaurin for adult patients with FLT3+ AML

    on April 28th, 2017
    The Food and Drug Administration has approved midostaurin for the treatment of FLT3 mutation–positive acute myeloid leukemia (FLT3+ AML) in adult patients in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Approval was based on results from a randomize[...]
  • Sarilumab showed sustained effect on RA progression at 3 years

    on April 28th, 2017
    AT RHEUMATOLOGY 2017 BIRMINGHAM, ENGLAND (FRONTLINE MEDICAL NEWS) – A “durable clinical response and stabilization of structural damage” was observed at 3 years of follow-up in the Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND) study. Désirée van der Hei[...]
  • In mantle cell lymphoma, triple therapy proves too toxic

    on April 24th, 2017
    FROM THE LANCET HAEMATOLOGY Combined idelalisib, lenalidomide, and rituximab proved excessively toxic for the treatment of relapsed and refractory mantle cell and follicular lymphoma in two phase I trials conducted by the Alliance for Clinical Trials in Oncology. The unexpected outcome, which led to[...]
  • Expanded drug combinations produce best myeloma induction

    on April 14th, 2017
    EXPERT ANALYSIS FROM A MEETING ON HEMATOLOGIC MALIGNANCIES NEW YORK (FRONTLINE MEDICAL NEWS) – Optimal induction therapy for patients with multiple myeloma requires all the therapeutic tools currently available for combination therapy, which means using four agents followed by autologous stem cell[...]
  • FDA approves Sovaldi, Harvoni for HCV in ages 12-plus

    on April 7th, 2017
    The Food and Drug Administration has approved the use of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) for the treatment of hepatitis C virus (HCV) in children aged 12 years and older. The drugs – the first direct-acting, potentially curative antiviral treatments approved for childr[...]
  • Myelofibrosis therapies moving beyond ruxolitinib

    on April 7th, 2017
    EXPERT ANALYSIS AT THE NCCN ANNUAL CONFERENCE ORLANDO (FRONTLINE MEDICAL NEWS) – Ruxolitinib is currently the only drug approved for the treatment of myelofibrosis, but a number of other therapies are in clinical trials and showing promise, according to Ruben A. Mesa, MD. “Our field … is r[...]
  • Avelumab produces durable responses in Merkel cell carcinoma

    on April 6th, 2017
    FROM AACR 2017 Avelumab (Bavencio) is the first drug to receive approval from the Food and Drug Administration for Merkel cell carcinoma, and new findings show that it elicited durable responses in this hard-to-treat population. The majority of responses were durable beyond 1 year, with an objective[...]
  • FDA approves deutetrabenazine for Huntington’s-associated chorea

    on April 4th, 2017
    The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of chorea associated with Huntington’s disease, according to an announcement by the drug’s manufacturer, Teva Pharmaceutical. The random, sudden, involuntary twisting and writhing movements of chorea const[...]
  • Osilodrostat maintained cortisol control in Cushing’s syndrome

    on April 4th, 2017
    AT ENDO 2017 ORLANDO (FRONTLINE MEDICAL NEWS) – Osilodrostat, a drug that normalized cortisol in 89% of patients with Cushing’s syndrome who took it during a phase II study, continued to exert a sustained benefit during a 31-month extension phase. In an intent-to-treat analysis, all of the 16 pa[...]
  • Hard road disproving that statins make you dumb

    on April 4th, 2017
    The impact of lipid-lowering drugs on patients’ mental states was on the minds of many attendees at the American College of Cardiology’s annual meeting in March. The highest-profile report came from EBBINGHAUS (Evaluating PCSK9 Binding Antibody Influence on Cognitive Health in High Cardiovascula[...]
  • Long-acting growth hormone moves forward based on positive phase II data

    on April 4th, 2017
    AT ENDO 2017 ORLANDO (FRONTLINE MEDICAL NEWS) – An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment. The two phase II studies ex[...]
  • Osimertinib receives full approval for advanced EGFR-mutated NSCLC

    on March 31st, 2017
    The Food and Drug Administration has converted accelerated approval of osimertinib to full approval for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. Also included[...]
  • Ocrelizumab gets first-ever FDA approval for primary progressive MS

    on March 29th, 2017
    The humanized monoclonal antibody ocrelizumab became the first drug to receive approval from the Food and Drug Administration for the treatment of primary progressive multiple sclerosis in adults, according to a March 29 announcement from the agency that also said it is approved for relapsing-remitt[...]
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