martedì, 5 maggio 2026

Notizie Newsletter

A multicenter, prospective phase II trial of gemcitabine plus axitinib in patients with renal cell carcinoma with a predominant sarcomatoid component

We conducted a multicenter, phase 2 trial using gemcitabine plus axitinib (GX) in patients with recurrent or metastatic sarcomatoid renal cell carcinoma (SRCC) to evaluate its efficacy and safety. Methods Patients with advanced RCC and a sarcomatoid component of ≥25% ...
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Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study

Pembrolizumab monotherapy has demonstrated durable antitumor activity in advanced programmed death ligand 1 (PD-L1) –expressing non‒small-cell lung cancer (NSCLC). We report 5-year outcomes from the phase Ib KEYNOTE-001 study. These data provide the longest efficacy ...
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FDA Approves Bevacizumab Biosimilar

June 28, 2019 - The FDA has approved PF-06439535 (bevacizumab-bvzr), a bevacizumab biosimilar for the treatment of patients with metastatic carcinoma of the colon or rectum; unresectable advanced, metastatic, or recurrent non–small cell lung cancer (NSCLC); advanced ...
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Atezolizumab Combo Approaches EU Approval for Frontline TNBC

June 28, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the frontline combination of atezolizumab plus nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or ...
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EU Panel Backs Expanded Indication of Ibrutinib Combos in CLL and Waldenstrom Macroglobulinemia

June 28, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indications of ibrutinib to include use in combination with obinutuzumab for adult patients with previously untreated chronic lymphocytic ...
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ASCO Commends the National Academies of Sciences, Engineering, and Medicine for its Report on Guiding Cancer Control

June 28, 2019 - “We applaud the National Academies of Sciences, Engineering, and Medicine for its recommendations on cancer control in the United States. The report examines the oncology community’s efforts over the past 10 years and lays out a comprehensive ...
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ASCO Launches Task Force to Address the Cancer Care Gap in Rural America

June 25, 2019 - Despite progress being made in cancer survivorship - there are currently nearly 17 million cancer survivors in the United States - not everyone is benefiting equally, especially those patients living in rural communities across America. According to “The ...
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FDA Lifts Partial Clinical Hold on Venetoclax Myeloma Trial

June 24, 2019 - The FDA has lifted a partial clinical hold that was placed on the phase III CANOVA (M13-494; NCT03539744) trial, which is examining venetoclax in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma that harbors ...
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FDA Approves Newly Designed Syringe for Lanreotide in GEP-NETs

June 24, 2019 - The FDA has granted an approval to a prefilled syringe for lanreotide, which has been designed to enable healthcare providers to administer the injection easier, for the treatment of adults with unresectable, well or moderately differentiated, locally advanced ...
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One additional country to benefit from EU-US mutual recognition agreement for inspections

June 27, 2019 - On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing ...
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