Notizie AIOM – anno XVII – Pagina 34

23 Agosto 2019

FDA Grants Acalabrutinib Breakthrough Designation for CLL

Aug 14, 2019 - The FDA has granted a breakthrough therapy designation to acalabrutinib for the treatment of patients with chronic lymphocytic leukemia (CLL). The designation is based on findings from the interim analyses of the phase III ELEVATE-TN and ASCEND (ACE-CL-309) ...
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23 Agosto 2019

FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

Aug 15, 2019 - The U.S. Food and Drug Administration today granted accelerated approval to entrectinib, a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there ...
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23 Agosto 2019

FDA Review Finds No Increased Risk of Prostate Cancer With Parkinson’s Disease Treatments Containing Entacapone

Aug 15, 2019 - A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. The FDA conducted this review after an earlier trial - the Stalevo Reduction in Dyskinesia ...
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23 Agosto 2019

FDA Approves Fedratinib for Myelofibrosis

Aug 16, 2019 - The FDA has approved fedratinib for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. The approval is based on findings from the phase III JAKARTA2 ...
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23 Agosto 2019

FDA OCE and Syapse Announce Research Collaboration Focused on Regulatory Use of Real-World Evidence

Aug 19, 2019 - Syapse and the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) have signed a multiyear research collaboration agreement focused on the use of real-world evidence to support regulatory decision-making. Syapse and the OCE will work ...
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23 Agosto 2019

Statement on new results demonstrating continued success of the agency’s youth smoking prevention efforts and significant public health cost savings

Aug 20, 2019 - As someone who has dedicated his life to reducing the public health burden and suffering caused by cancer, it is all too clear that we must do everything we can to prevent kids from starting down a path of a lifelong addiction to tobacco and its associated ...
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23 Agosto 2019

FDA Grants Enzalutamide Priority Review for Metastatic Hormone-Sensitive Prostate Cancer

Aug 21, 2019 - The FDA has granted a priority review designation to a supplemental new drug application for enzalutamide for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC), according to Astellas Pharma Inc. and Pfizer Inc., the codevelopers ...
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23 Agosto 2019

FDA Grants Zanubrutinib Priority Review for Relapsed/Refractory Mantle Cell Lymphoma

Aug 21, 2019 - The FDA has granted a priority review designation to a new drug application (NDA) for zanubrutinib (BGB-3111) for the treatment of patients with mantle cell lymphoma (MCL) who have received ≥1 prior therapy. The application is based on data from an international ...
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23 Agosto 2019

Elotuzumab Triplet Approaches EU Approval for Multiple Myeloma

July 29, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approving elotuzumab for use in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple ...
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23 Agosto 2019

Atezolizumab Plus Chemo Poised for EU Approval in Small Cell Lung Cancer

July 29, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of atezolizumab in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung ...
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LAVORIAMO CON

News

LA PREVENZIONE DEL MELANOMA: AL VIA UNA CAMPAGNA NEI COOP.FI

TUMORI: “AIFA APPROVA LA FORMULAZIONE SOTTOCUTANEA E TRE NUOVE INDICAZIONI TERAPEUTICHE DI NIVOLUMAB”

TUMORE AL SENO: METASTASI SI DIFFONDONO COME GOCCE SU UNA SUPERFICIE. LA CAPACITÀ INVASIVA DIPENDE DALLA “FLUIDITÀ” DEL CANCRO

ONE HEALTH FOUNDATION: AL VIA IL PROGETTO IN 36 CENTRI ESTIVI IN ALBANIA. SULLA “NAVE DELLA SALUTE” SVOLTI PIU’ DI 550 TEST E VISITE MEDICHE

AL VIA LA TERZA EDIZIONE DELLA “NAVE DELLA SALUTE” ITALIA-ALBANIA. LA PREVENZIONE SALE A BORDO CON 17 MEDICI SPECIALISTI E 10 AMBULATORI

TOVORAFENIB È LA PRIMA TERAPIA MIRATA APPROVATA IN EUROPA NEL GLIOMA PEDIATRICO DI BASSO GRADO RECIDIVATO O REFRATTARIO, INDIPENDENTEMENTE DAL TIPO DI ALTERAZIONE DI BRAF

TOZORAKIMAB HA SODDISFATTO L’ENDPOINT PRIMARIO DELLO STUDIO DI FASE III MIRANDA NEI PAZIENTI CON BPCO

Notizie AIOM – anno XVII

FDA Grants Acalabrutinib Breakthrough Designation for CLL

FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

FDA Review Finds No Increased Risk of Prostate Cancer With Parkinson’s Disease Treatments Containing Entacapone

FDA Approves Fedratinib for Myelofibrosis

FDA OCE and Syapse Announce Research Collaboration Focused on Regulatory Use of Real-World Evidence

Statement on new results demonstrating continued success of the agency’s youth smoking prevention efforts and significant public health cost savings

FDA Grants Enzalutamide Priority Review for Metastatic Hormone-Sensitive Prostate Cancer

FDA Grants Zanubrutinib Priority Review for Relapsed/Refractory Mantle Cell Lymphoma

Elotuzumab Triplet Approaches EU Approval for Multiple Myeloma

Atezolizumab Plus Chemo Poised for EU Approval in Small Cell Lung Cancer