sabato, 8 agosto 2026

Notizie AIOM – anno XVII n. 728

Talazoparib Approved in Europe for BRCA-Mutant Breast Cancer

June 21, 2019 - The European Commission has approved single-agent talazoparib for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer. The approval is based on findings from the phase III EMBRACA study, ...
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Immune Checkpoint Inhibitor Outcomes for Patients With Non-Small-Cell Lung Cancer Receiving Baseline Corticosteroids for Palliative Versus Nonpalliative Indications

Baseline use of corticosteroids is associated with poor outcomes in patients with non-small-cell lung cancer (NSCLC) treated with programmed cell death-1 axis inhibition. To approach the question of causation versus correlation for this association, we examined outcomes ...
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Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial

Late-line treatment options for patients with ovarian cancer are few, with the proportion of patients achieving an overall response typically less than 10%, and median overall survival after third-line therapy of 5-9 months. In this study (QUADRA), we investigated the activity ...
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21 giugno 2019 – Carenza Procarbazina cloridrato (Leadiant) – modalità di richiesta d’Importazione dall’estero

21 giugno 2019 – Horizon Scanning. AIFA pubblica il primo rapporto “Orizzonte Farmaci. Scenario dei medicinali in arrivo”

Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics

June 20, 2019 - Addressing the crisis of opioid addiction is an issue of great concern for our nation and remains a top public health priority for the FDA. The agency continues to take new steps to confront this crisis, while also paying careful attention to the needs of ...
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FDA Issues Complete Response Letter for Quizartinib in AML

June 21, 2019 - The FDA has issued a complete response letter to Daiichi Sankyo informing the company that its new drug application (NDA) would not be approved for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid ...
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U.S. Cancer Survivors Numbered Nearly 17 Million at the Start of 2019

June 17, 2019 - There were more than 16.9 million Americans with a history of cancer on January 1, 2019, and that number is projected to reach more than 22.1 million by 2030 based on the growth and aging of the population alone, according to estimates from Cancer Treatment ...
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Olaparib Approved in Japan for Frontline Maintenance in Ovarian Cancer

June 19, 2019 - Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved olaparib as a maintenance treatment for patients with BRCA-mutant ovarian cancer after undergoing first-line chemotherapy. The approval was based on findings from the randomized, double-blinded, ...
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Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

June 18, 2019 - The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs. The U.S. ...
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