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FDA Approves Letairis (Ambrisentan) Generics for PAH.

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The US Food and Drug Administration (FDA) has approved four generic versions of Gilead Sciences’ Letairis (ambrisentan), an endothelin receptor antagonist indicated for treatment for pulmonary arterial hypertension (PAH). The FDA first approved Letairis for PAH in 2007. Three generics are from Mylan Pharmaceuticals, Watson Laboratories, and Sun Pharma Global. The fourth generic is from Zydus Pharmaceuticals. In order to accommodate all four…

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Long-Term Androgen Deprivation Underused for Prostate Cancer.

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  Long-duration androgen deprivation therapy (ADT) is widely underused in men, especially African Americans, who are undergoing definitive external beam radiotherapy (EBRT) for high-grade prostate cancer, a new U.S. study has found. Nearly a quarter of patients in the population-based retrospective trial received no long-term ADT, and fewer than one in seven received the recommended…

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Cabozantinib Shows Promise in Non-Clear-Cell Kidney Cancer.

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  While there has been much progress made in recent years in the treatment of kidney cancer, all of it has been in the most common form of this disease, clear-cell renal cell carcinoma (ccRCC). Patients with the less common type of kidney cancer, non-clear-cell renal cell carcinoma (nccRCC), have usually been excluded from the large trials.…

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Half A Million Breast Cancer Deaths Avoided In Last 30years.

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  Progress in both detection and management of breast cancer may have saved the lives of hundreds of thousands of women over the past three decades, according to a new report. The cumulative number of breast cancer deaths that have been averted since 1989 ranges between 384,000 and 614,500, depending on different background mortality assumptions.…

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Darolutamide : New Standard Of Care In Non Metastatic CRPC

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  Treatment with the investigational agent darolutamide (Bayer/Orion) significantly extended metastasis-free survival in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), results from the phase 3 ARAMIS trial show. Darolutamide prolonged metastasis-free survival to 40.4 months, which was 22 months longer than observed with placebo, and the risk of metastasis or death from any cause was…

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Checkpoint Inhibitor ‘Not Off Table’ For Patients With A History Of Autoimmune Disease.

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This is Mark Kris from Memorial Sloan Kettering, speaking today about an emerging issue in our treatment of patients with lung cancers, and that is the use of immune checkpoint inhibitors in patients with a history of prior autoimmune disease. Many of us know that these patients were, by and large, excluded from clinical trials,…

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‘Impressive’ Activity with BRAF/MEK Inhibitors in Biliary Cancer

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Biliary tract cancers (BTCs) are rare, aggressive malignancies that generally have a poor prognosis, and are usually treated with chemotherapy. A new study shows that in a subgroup of these patients, individuals who have tumors with BRAF V600E mutations, treatment with a combination of targeted agents showed promising activity. The combination of drugs used — the BRAF kinase inhibitor…

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Four Major Developments in Multiple Myeloma: ASH 2018

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Frontline Monoclonal Antibody Therapy for Multiple Myeloma The first is the move toward monoclonal antibody therapy in frontline multiple myeloma. Earlier this year, the US Food and Drug Administration (FDA) approved daratumumab in combination with bortezomib, melphalan, and prednisone in patients who were ineligible for an autologous stem cell transplant, based on a clinical trial that demonstrated…

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