lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

Dacomitinib Approved in Europe for Frontline EGFR+ NSCLC

April 3, 2019 - The European Commission has approved dacomitinib for the frontline treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR-activating mutations, according to Pfizer, the manufacturer of the pan-human ...
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Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

March 28, 2019 - Our comprehensive plan on tobacco and nicotine regulation, unveiled in July 2017, aims to tackle the leading cause of preventable death in the U.S. by focusing on two key areas: reducing the nicotine levels in combustible cigarettes to render them minimally ...
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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

March 29, 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for treatment, outside of participation in a clinical trial, when appropriate. The FDA remains deeply committed to this effort. Helping to facilitate ...
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IT systems unavailable from 30 March to 1 April 2019

March 26, 2019 - All European Medicines Agency (EMA) information technology (IT) systems will be temporarily unavailable from 08:30 on Saturday 30 March to 6:00 on Monday 1 April (Central European Time, CET), due to the changeover to re-state the time zone on EMA's servers ...
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019

March 29, 2019 - EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorisation and three extensions of indication at its first meeting in Amsterdam in March 2019. The Committee recommended granting a conditional marketing ...
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EU Panel Backs Lenalidomide- and Pomalidomide-Based Triplets for Myeloma

March 29, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted positive opinions to 2 triplet regimens with immunomodulatory agents (IMiDs) for patients with multiple myeloma. The first 3-drug treatment is lenalidomide ...
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FDA Oncology Center of Excellence Issues Annual Report

March 29, 2019 - The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has issued its 2018 Annual Report, including updates on regulatory reviews and initiatives, OCE programs, guidances, and more. The OCE is tasked with clinical medical oncology ...
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Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)

Real-world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell ...
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Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer

Patients who have residual invasive breast cancer after receiving neoadjuvant chemotherapy plus human epidermal growth factor receptor 2 (HER2)-targeted therapy have a worse prognosis than those who have no residual cancer. Trastuzumab emtansine (T-DM1), an antibody-drug ...
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Plasma Androgen Receptor and Docetaxel for Metastatic Castration-resistant Prostate Cancer

Plasma androgen receptor (AR) gain identifies metastatic castration-resistant prostate cancer mCRPC) patients with worse outcome on abiraterone/enzalutamide, but its relevance in the context of taxane chemotherapy is unknown. We aimed to evaluate whether docetaxel is active ...
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