giovedì, 15 ottobre 2026

Notizie AIOM – anno XVI n. 675

Inaugural Guidelines for Patients With HIV Aim to Expand Therapy Options

May 12, 2018 - The HIV status of a patient who is living with the infection and has been diagnosed with cancer may be a component of a diagnostic workup but should not be the sole determining factor in making decisions about treatment, according to the first set of National ...
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FDA Grants Fast Track Designation to Debio 1347 for Unresectable or Metastatic Tumors With a Specific FGFR Gene Alteration

May 11, 2018 - Debiopharm International SA (Debiopharm) recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Debio 1347, an inhibitor of fibroblast growth factor receptors 1, 2, and 3 (FGFR1–3), for the treatment ...
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Expert Underscores Importance of AE Management in GU Cancers

May 9, 2018 - Although they tend to be less common, adverse event (AE) management is still imperative with immunotherapies and requires a multidisciplinary approach, says Xiao X. Wei, MD, MAS. While revisions to the ASCO, NCCN, and ESMO guidelines have given clinicians a ...
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NCCN Crafts First Guidelines for Uveal Melanoma

May 13, 2018 - The unique biological characteristics of uveal melanoma have prompted the National Comprehensive Cancer Network (NCCN) to develop the first set of guidelines for the diagnosis and management of the rare but deadly cancer, according to Christopher A. Barker, ...
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Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices

May 11, 2018 - Today is an important day in the Administration’s collaborative effort to address the rising cost of drugs. We know that the high list cost of drugs can adversely impact peoples’ access to medicines. People rely on medicines to improve their quality ...
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FDA Grants Frontline Atezolizumab Priority Review for NSCLC

May 7, 2018 - The FDA has granted a priority review to a supplemental biologics license application (sBLA) for atezolizumab for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non–small ...
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FDA Approves Frontline Daratumumab/VMP Combo for Multiple Myeloma

May 8, 2018 - The FDA has approved daratumumab in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT), based on findings from the ALCYONE ...
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Rucaparib FDA Approval Creates Trifecta of Maintenance PARP Inhibitors in Ovarian Cancer

May 8, 2018 - There are now 3 FDA-approved PARP inhibitors in the maintenance setting -niraparib, olaparib, and rucaparib- for patients with ovarian cancer who are in a complete or partial response to platinum-based chemotherapy. The April 2018 approval of rucaparib was ...
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FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan

May 10, 2018 - The U.S. Food and Drug Administration today issued four new warning letters to manufacturers and retailers for selling e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products, such as cereal, soda ...
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Two years of PRIME. Driving innovation to where it is most needed

May 8, 2018 - In the two years since its launch, the PRIority Medicines scheme (PRIME) of the European Medicines Agency (EMA) has succeeded in driving innovation and improved the efficiency of the development process in therapeutic areas with the most pressing unmet medical ...
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