Notizie Newsletter
FDA Grants Durvalumab Orphan Drug Status in Small Cell Lung Cancer
July 12, 2019 - The FDA has granted an Orphan Drug Designation to durvalumab for the treatment of patients with small cell lung cancer (SCLC), according to AstraZeneca, the developer of the PD-L1 inhibitor. The designation follows the announcement of the phase III CASPIAN ...Leggi tutto
Medicaid Patients Need Clinical Trial Access, Coalition Tells Congress
July 10, 2019 - Today, organizations representing patients, providers, medical researchers, survivors, and their families joined together to call on Congress to improve access to clinical trials for patients with life-threatening diseases. The coalition, which is made up ...Leggi tutto
FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications
July 9, 2019 - The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions. The new dosage would be applicable for the PD-1 inhibitor’s ...Leggi tutto
FDA Grants Fast Track Designation to CLR 131 for DLBCL
July 11, 2019 - The FDA has granted a fast track designation to CLR 131 for use as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The designation is based on findings from a DLBCL cohort that is part of the ongoing phase II CLOVER-1 ...Leggi tutto
Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities (ICMRA)
July 8, 2019 - The International Coalition of Medicines Regulatory Authorities (ICMRA) has elected EMA’s Executive Director Guido Rasi as its new chair. ICMRA brings together the leaders of regulatory authorities around the world to provide strategic directions for ...Leggi tutto
Pembrolizumab in men with heavily treated metastatic castrate-resistant prostate cancer
Pembrolizumab is approved for patients with metastatic, microsatellite instability (MSI)-high or mismatch repair-deficient (dMMR) solid tumors. However, very few men with prostate cancer were included in these initial studies. We performed a single institution retrospective ...Leggi tutto
Development and validation of a prognostic nomogram for overall survival in patients with platinum-resistant ovarian cancer treated with chemotherapy
Platinum-resistant ovarian cancer (PROC) is associated with a variable prognosis and unpredictable survival times. We have developed and validated a prognostic nomogram with the objective of improving the prediction of overall survival (OS) in patients treated with chemotherapy. ...Leggi tutto