Notizie AIOM – anno XVII n. 721

7 Maggio 2019

Re-analysis of data on use of breast cancer medicine Lapatinib following treatment with trastuzumab

April 30, 2019 - EMA is updating the prescribing information for lapatinib following detection of errors in results of a study involving postmenopausal women who had ‘HR+/HER2+’ breast cancer and whose disease had worsened despite previous treatment with trastuzumab. ...
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6 Maggio 2019

The humanistic burden associated with caring for patients with advanced non-small cell lung cancer (NSCLC) in three European countries-a real-world survey of caregivers

This study evaluated the humanistic burden on caregivers of patients with advanced non-small cell lung cancer (aNSCLC) as the disease progresses. Data were drawn from a cross-sectional study of patients with aNSCLC and their caregivers conducted in France, Germany, and Italy ...
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6 Maggio 2019

Immunotherapy in organ-transplanted cancer patients: efficacy and risk of organ rejection

Organ-transplanted patients have a significantly higher risk of developing solid tumors (1). These patients are systematically excluded from clinical trials, so their available therapeutic options are very limited. With the incorporation of immunotherapy to cancer treatment ...
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6 Maggio 2019

FDA Approves Adjuvant T-DM1 in HER2+ Early Breast Cancer

May 3, 2019 - The FDA has approved ado-trastuzumab emtansine (T-DM1) for use as an adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant trastuzumab and chemotherapy. The approval is based on findings ...
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6 Maggio 2019

EMA annual report 2018 published

May 3, 2019 - The annual report published today provides an overview of the Agency’s activities to protect and promote the health of people and animals in the EU and highlights EMA’s most significant achievements in 2018. As in previous editions, an entire chapter ...
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3 Maggio 2019

FDA Approval Sought for Apalutamide in Metastatic Castration-Sensitive Prostate Cancer

April 29, 2019 - A supplemental new drug application (sNDA) has been submitted to the FDA for the approval of apalutamide for use as a treatment of patients with metastatic castration-sensitive prostate cancer, according to Janssen, the manufacturer of the next-generation ...
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3 Maggio 2019

Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants

May 2, 2019 - There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has ...
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3 Maggio 2019

FDA Approves Ivosidenib for Frontline IDH1+ AML

May 2, 2019 - The FDA has approved a supplemental new drug application (sNDA) for ivosidenib as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia (AML), as detected by an FDA-approved test, who are ≥75 years old or ...
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3 Maggio 2019

EU Panel Recommends Revoking Olaratumab in Soft Tissue Sarcoma

April 29, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the conditional marketing authorization for olaratumab be revoked following results of the ANNOUNCE study, which did not demonstrate a survival ...
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3 Maggio 2019

Talazoparib Approaches EU Approval for BRCA-Mutated, HER2-Negative Breast Cancer

April 29, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed approval of talazoparib for adult patients with HER2-negative locally advanced or metastatic breast cancer harboring germline BRCA1/2 mutations, according to ...
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TUMORE DELL’OVAIO, 1 DONNA SU 3 ASPETTA PIÙ DI UN ANNO PER LA DIAGNOSI. “NECESSARIO AUMENTARE L’ACCESSO AI CENTRI AD ALTO VOLUME, AL SUPPORTO PSICONCOLOGICO E ALL’INNOVAZIONE TERAPEUTICA”

TUMORE DEL SENO, IN ITALIA 950MILA DONNE VIVONO CON UNA DIAGNOSI. ROPI: ‘RACCOMANDATI ALMENO 150 MINUTI D’ATTIVITA’ FISICA ALLA SETTIMANA’

Notizie AIOM – anno XVII n. 721

Re-analysis of data on use of breast cancer medicine Lapatinib following treatment with trastuzumab

The humanistic burden associated with caring for patients with advanced non-small cell lung cancer (NSCLC) in three European countries-a real-world survey of caregivers

Immunotherapy in organ-transplanted cancer patients: efficacy and risk of organ rejection

FDA Approves Adjuvant T-DM1 in HER2+ Early Breast Cancer

EMA annual report 2018 published

FDA Approval Sought for Apalutamide in Metastatic Castration-Sensitive Prostate Cancer

Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants

FDA Approves Ivosidenib for Frontline IDH1+ AML

EU Panel Recommends Revoking Olaratumab in Soft Tissue Sarcoma

Talazoparib Approaches EU Approval for BRCA-Mutated, HER2-Negative Breast Cancer