sabato, 2 maggio 2026

Notizie Newsletter

Pazdur Followed the Pathway of Greatest Resistance to the FDA

December 30, 2019 - Richard Pazdur, MD, a 2019 winner of the OncLive® Giants of Cancer Care® award for community outreach, education, and cancer policy, set out to be a leader in medicine and a teacher of doctors. He achieved that and more, turning the oncology drugs ...
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FDA Approves Olaparib for Frontline Maintenance in Pancreatic Cancer

December 30, 2019 - The FDA has approved the PARP inhibitor olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy ...
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Adjuvant T-DM1 Approved in Europe for HER2+ Early Breast Cancer

December 19, 2019 - The European Commission has approved ado-trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based ...
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Phase II Trial of Cediranib in Combination With Cisplatin and Pemetrexed in Chemotherapy-Naïve Patients With Unresectable Malignant Pleural Mesothelioma (SWOG S0905)

Antiangiogenic agents combined with chemotherapy have efficacy in the treatment of unresectable malignant pleural mesothelioma (MPM). Cediranib (AstraZeneca, Cheshire, United Kingdom), a vascular endothelial growth factor receptor and platelet-derived growth factor receptor ...
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Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer

Patients with metastatic colorectal cancer with the BRAF V600E mutation have a poor prognosis, with a median overall survival of 4 to 6 months after failure of initial therapy. Inhibition of BRAF alone has limited activity because of pathway reactivation through epidermal ...
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Opportunità di lavoro in Oncologia

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FDA Approval Sought for Rituximab Biosimilar

December 20, 2019 - A biologics license application has been submitted to the FDA for the rituximab biosimilar ABP 798, according to the developers, Amgen and Allergan. The application is based on analytical, pharmacokinetic, and clinical data, and also pharmacology and ...
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FDA Approval Sought for Margetuximab in HER2+ Metastatic Breast Cancer

December 20, 2019 - MacroGenics, Inc. has submitted a biologics license application (BLA) for margetuximab for use in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The BLA is based on data from the phase III SOPHIA ...
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FDA Grants ADP-A2M4 RMAT Designation for Synovial Sarcoma

December 23, 2019 - The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ADP-A2M4 (MAGE-A4) as a treatment for patients with synovial sarcoma. The RMAT designation was based on updated data from a phase I trial that was presented at the 2019 ...
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FDA Approval Sought for Selinexor in DLBCL

December 23, 2019 - Karyopharm Therapeutics Inc., has submitted a new drug application (NDA) to the FDA for selinexor for the treatment of patients with relapsed/refractory diffuse large B-Cell lymphoma (DLBCL) who have received at least 2 prior multiagent therapies and ...
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