FDA approved stamp

FDA Extends Five Indications of Anticancer Agents in November

In November 2017, the United States Food and Drug Administration (FDA) issued new indications for five previously approved anticancer agents. Adjuvant Sunitinib Approved in Renal Cell Carcinoma. The FDA expanded the indication of sunitinib (Sutent®, Pfizer) in renal cell carcinoma (RCC) to include use as adjuvant therapy following nephrectomy in patients at high risk for[…]

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lung cancer, NSCLC, lung tumor

Is Adjuvant Gefitinib Superior to Chemotherapy in Early Stage Non-Small Cell Lung Cancer?

Epidermal growth factor receptor (EGFR)–targeting tyrosine kinase inhibitors (TKIs) are the recommended initial therapy for metastatic EGFR-mutant non-small cell lung cancer (NSCLC), based on prolonged progression free survival (PFS) and improved quality of life compared to chemotherapy in several phase III trials. For patients with resected stage II and III NSCLC, cisplatin-based adjuvant chemotherapy is[…]

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Four Interesting Reviews You May Have Missed

Four Interesting Reviews You May Have Missed Checkpoint Blockade for Breast Cancer. In recent years immunotherapy with immune checkpoint inhibitors has become standard of care for several hard-to-treat cancers. Breast cancer was initially considered a nonimmunogenic tumor, but recent evidence of the prognostic/predictive role of the immune system has led to the investigation of immunotherapeutic[…]

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Moving Brentuximab Vedotin Into the First-Line Therapy for Hodgkin Lymphoma

Moving Brentuximab Vedotin Into the First-Line Therapy for Hodgkin Lymphoma In patients with early unfavorable and advanced-stage Hodgkin lymphoma, front-line therapy that includes escalated BEACOPP (eBEACOPP: bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) improves survival compared to ABVD therapy (doxorubicin, bleomycin, vinblastine, and dacarbazine). However, this regimen is associated with higher risk of grade[…]

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gut microbiome, melanoma, PD-1

Gut Microbiome Influences Response to PD-1 Targeted Immunotherapy

Although immune checkpoint inhibitors targeting the cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) and PD-1 signaling pathways induce long-lasting tumor responses in patients with melanoma, responses to these agents are often heterogeneous and not durable. The clinical and patient characteristics influencing response to immune checkpoint inhibitors are not well understood. The importance of the gut microbiome in[…]

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lung cancer

Prior Treatment With PD-1/PD-L1 Inhibitors Improves Responses to Salvage Chemotherapy in NSCLC

Immune checkpoint inhibitors have significantly reshaped the treatment landscape of advanced non-small cell lung cancer (NSCLC) in the second-line and, more recently, in the first-line setting. However, only a subset of patients achieves a durable response on immunotherapy, and it is not clear whether prior immunotherapy treatment impacts response to salvage chemotherapy. A recent retrospective[…]

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EMA Gives Green Light to Three Oncology Agents in October

On 12 October 2017, the European Medicines Agency (EMA) issued positive opinions supporting approval of expanded indications for three oncology treatments. Alectinib for First-Line Therapy of ALK-Rearranged Lung Adenocarcinoma. The anaplastic lymphoma kinase (ALK) inhibitor alectinib (Alecensa®, Roche) was previously approved only for ALK-positive patients who had progressed on crizotinib. The EMA recommendation to extend[…]

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ctDNA biomarker PD1 efficacy on melanoma

Circulating Tumor DNA As Biomarker of Efficacy for Immune Checkpoint Inhibitors in Melanoma

Immune checkpoint inhibitors targeting the programmed death receptor 1 (PD-1) axis are current standards of care for metastatic melanoma as single agents or in combination with the CTLA-4 inhibitor ipilimumab, but more than half of patients do not respond to immunotherapy.   Unfortunately, there are no reliable biomarkers available in melanoma to accurately predict for success[…]

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Dabrafenib and Trametinib, Effective Combination for BRAF-Mutated Anaplastic Thyroid Cancer

The combination of a BRAF inhibitor with a MEK inhibitor is a standard of care in patients with metastatic melanoma and non-small cell lung cancer harboring BRAF V600E mutations. These mutations occur in between 20% to 50% of patients with anaplastic thyroid cancer, a rare malignancy considered to be one of the most lethal of[…]

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primelines FDA Approvals July 2017 breast cancer melanoma ALL

FDA Approves Three New Treatments in Hematology and Oncology in October

In October, the US Food and Drug Administration (FDA) approved three new agents for hematology and oncology, including a second chimeric antigen receptor modified T-cell (CAR T-cell) therapy, a Bruton’s tyrosine kinase (BTK) inhibitor for mantle cell lymphoma, and an IV formulation of rolapitant. New CAR T-Cell Therapy Approved for Non-Hodgkin Lymphoma. On 18 October, the FDA approved[…]

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