Enfortumab Vedotin Active in Advanced Pretreated Urothelial Carcinoma

Cisplatin-based combination chemotherapy is the standard first-line therapy for patients with metastatic urothelial cancer (UC). Patients with high PD-L1 expression who are not eligible for platinum chemotherapy may receive first-line treatment with immune checkpoint inhibitors, pembrolizumab or atezolizumab. Following progression on platinum-based chemotherapy, most patients are treated with one of the five PD-(L)1 inhibitors currently […]

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Chemotherapy-Free Regimen for Platinum-Sensitive Ovarian Cancer

Platinum-based chemotherapy followed by poly(ADP-ribose) polymerase (PARP) inhibitor maintenance is the established standard of care for platinum-sensitive recurrent ovarian cancer. However, use of platinum-based chemotherapy is limited due to risk of cumulative toxicity. The PARP inhibitor niraparib has demonstrated efficacy both as maintenance therapy following platinum chemotherapy (NOVA trial) and as a monotherapy in pretreated […]

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Ribociclib/ET Combo Extends Survival in Premenopausal Breast Cancer

For patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, combination therapy with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy (ET) is standard first-line therapy for both postmenopausal and premenopausal patients based on substantial improvement of progression-free survival (PFS) in randomized phase III trials. However, significant improvement […]

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Maintenance Olaparib Prolongs PFS in BRCA-Mutated Pancreatic Cancer

The prognosis of patients with metastatic pancreatic cancer (mPCA) remains poor, despite use of modern chemotherapy regimens such as FOLFIRINOX and nab-paclitaxel/gemcitabine. After progression on frontline therapy, less than half of the patients are eligible for second-line treatment. There is a high, unmet need for targeted biomarker selected treatment approaches. In ovarian and breast cancer, […]

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Enzalutamide Improves Survival in Hormone-Sensitive Prostate Cancer

The treatment of metastatic hormone-sensitive prostate cancer (HSPC) has undergone a major evolution in recent years. While androgen deprivation therapy (ADT) remains the backbone of care, several studies have demonstrated an improvement in long-term survival when the cytotoxic agent docetaxel or the androgen biosynthesis inhibitor abiraterone are added to ADT. Enzalutamide is a potent direct […]

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Pembrolizumab ± Chemotherapy, a New First-Line Standard for HNSCC

For the past decade, the standard first-line treatment for patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) has been the combination of cetuximab, platinum chemotherapy, and 5-FU followed by cetuximab maintenance, commonly referred to as the “EXTREME regimen.” However, while this regimen results in a 10.1-month overall survival (OS), it is associated […]

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fda-approvals-june-2019

New Oncology and Hematology Indications Approved by FDA in May

PI3K Inhibitor Alpelisib for PIK3CA-mutated Advanced Breast Cancer. The phosphoinositide 3-kinase (PI3K) inhibitor alpelisib (Piqray®, Novartis Pharmaceuticals Corporation) was approved for use in combination with fulvestrant for treatment of postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer following progression on or after an endocrine containing regimen. To […]

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