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10.1007/s11060-021-03789-5 http://scihub22266oqcxt.onion/10.1007/s11060-021-03789-5 34156585!8218275!34156585     free     free     free Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       J+Neurooncol 2021 ; 153 (3): 375-381 Nephropedia Template TP {{tp|p=34156585|t=2021. US Food and Drug Administration regulatory updates in neuro-oncology |pdf=|usr=}}{{34156585}} gab.com Text US Food and Drug Administration regulatory updates in neuro-oncology JO: J Neurooncol http://www.kidney.de/pget.php?&tw=1&pmid=34156585 #FOAvip OBJECTIVE: Contemporary management of patients with neuro-oncologic disease requires an understanding of approvals by the US Food and Drug Administration (FDA) related to nervous system tumors. To summarize FDA updates applicable to neuro-oncology practitioners, we sought to review oncology product approvals and Guidances that were pertinent to the field in the past year. METHODS: Oncology product approvals between January 1, 2020, and December 31, 2020, were reviewed for clinical trial outcomes involving tumors of the nervous system. FDA Guidances relevant to neuro-oncology were also reviewed. RESULTS: Five oncology product approvals described outcomes for nervous system tumors in the year 2020. These included the first regulatory approval for neurofibromatosis type 1: selumetinib for children with symptomatic, inoperable plexiform neurofibromas. Additionally, there were 4 regulatory approvals for non-central nervous system (CNS) cancers that described clinical outcomes for patients with brain metastases. These included the approval of tucatinib for metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer including patients with brain metastases, brigatinib for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), and pralsetinib and selpercatinib for RET fusion-positive NSCLC. Finally, two FDA Guidances for Industry, "Cancer Clinical Trial Eligibility Criteria: Brain Metastases" and "Evaluating Cancer Drugs in Patients with Central Nervous System Metastases" were published to facilitate drug development for and inclusion of patients with CNS metastases in clinical trials. CONCLUSIONS: Despite the challenges of the past year brought on by the COVID-19 pandemic, progress continues to be made in neuro-oncology. These include first-of-their-kind FDA approvals and Guidances that are relevant to the management of patients with nervous system tumors. Twit Text FOAVip US Food and Drug Administration regulatory updates in neuro-oncology ????J Neurooncol http://www.kidney.de/pget.php?&tw=1&pmid=34156585 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34156585 #FOAvip English Wikipedia <ref>{{Cite pmid|34156585}}</ref> US Food and Drug Administration regulatory updates in neuro-oncology #MMPMID34156585 Mehta GU; Barone AK; Bradford D; Larkins E; Kim J; Pai-Scherf L; Jaigirdar A; Shah M; Wedam S; Amiri-Kordestani L; Theoret MR; Pazdur R; Beaver JA; Singh H J Neurooncol 2021[Jul]; 153 (3): 375-381 PMID34156585show ga OBJECTIVE: Contemporary management of patients with neuro-oncologic disease requires an understanding of approvals by the US Food and Drug Administration (FDA) related to nervous system tumors. To summarize FDA updates applicable to neuro-oncology practitioners, we sought to review oncology product approvals and Guidances that were pertinent to the field in the past year. METHODS: Oncology product approvals between January 1, 2020, and December 31, 2020, were reviewed for clinical trial outcomes involving tumors of the nervous system. FDA Guidances relevant to neuro-oncology were also reviewed. RESULTS: Five oncology product approvals described outcomes for nervous system tumors in the year 2020. These included the first regulatory approval for neurofibromatosis type 1: selumetinib for children with symptomatic, inoperable plexiform neurofibromas. Additionally, there were 4 regulatory approvals for non-central nervous system (CNS) cancers that described clinical outcomes for patients with brain metastases. These included the approval of tucatinib for metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer including patients with brain metastases, brigatinib for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), and pralsetinib and selpercatinib for RET fusion-positive NSCLC. Finally, two FDA Guidances for Industry, "Cancer Clinical Trial Eligibility Criteria: Brain Metastases" and "Evaluating Cancer Drugs in Patients with Central Nervous System Metastases" were published to facilitate drug development for and inclusion of patients with CNS metastases in clinical trials. CONCLUSIONS: Despite the challenges of the past year brought on by the COVID-19 pandemic, progress continues to be made in neuro-oncology. These include first-of-their-kind FDA approvals and Guidances that are relevant to the management of patients with nervous system tumors. |Antineoplastic Agents/*therapeutic use[MESH] |Brain Neoplasms/*drug therapy[MESH] |Drug Approval/*legislation & jurisprudence/*methods[MESH] |Humans[MESH] |United States[MESH]US Food and Drug Administration regulatory updates in neuro-oncology (epmc).pdf DeepDyve Pubget Overpricing