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FDA-cleared genomic profiling tests to guide cancer treatment

December 25, 2017 – The American Food & Drug Administration (FDA) has approved two genetic tests to identify genetic alterations in tumors.  The FoundationOne CDx (F1CDx) genomic test and the MSK-IMPACT Tumor Profiling test both can help to guide physicians in clinical trial enrollment and in cancer treatment.

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Vemurafenib (Zelboraf) for BRAF V600E positive Erdheim-Chester Disease (ECD)

Dezember 21, 2017 – Erdheim–Chester disease ((ECD), also known as Erdheim–Chester syndrome or polyostotic sclerosing histiocytosis) is a form of a bone marrow borne blood cancer. It is a rare disease characterized by the abnormal multiplication of a specific type of white blood cells called histiocytes,

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Cobimetinib (Cotellic) is now approved as part of a combination treatment with Vemurafenib (Zelboraf) for advanced melanoma

November 13, 2015 – The American Food and Drug Administration (FDA) just approved Cobimetinib (Cotellic) to be used in combination with Vemurafenib (Zelboraf) to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

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Vemurafenib [Zelboraf] Approved Together with a Companion Diagnostic Test by FDA for Advanced Melanoma in BRAF V600E Positive Patients

August 17, 2011 — The US Food and Drug Administration (FDA) has just approved the oral targeted therapy Vemurafenib [Zelboraf] for the first-line treatment of both metastatic and unresectable melanomas. The drug is specifically indicated for patients with melanoma whose tumors have V600E mutations in the BRAF gene. An estimated 50% of patients with melanoma have this type of BRAF mutation,

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Dabrafenib [Tafinalar] and Trametinib [Mekinist] Approved for BRAF V600 Mutated Metastatic Melanoma

May 30, 2013 – From a Medscape News Release we learn today that two new drugs have been approved by the US Food and Drug Administration (FDA) for use in certain patients with metastatic or unresectable melanoma, along with a diagnostic test to identify patients who are suitable for treatment.

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Can We Identify Risk for Drug Toxicity?

October 10, 2013 – Very recently, David Kerr, Professor of Cancer Medicine at University of Oxford, in the United Kingdom, and past President of the European Society for Medical Oncology, talked on Medscape (see the video here) about risk-benefit analyses for novel, inventive cancer treatments. See here in italics his statement:

 When we talk about precision medicine and personalized medicine,

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Patients on Vemurafenib [Zelboraf] Need Testing for RAS Mutations: Secondary Cancers a Major Concern

January 26, 2012 – A January 20, 2012 article in Medscape Medical New illustrates how personalized medicine can be tricky. The case is Vemurafenib [Zelboraf], which was introduced to the market together with an companion genetic test mid 2011 for the treatment of advanced melanoma in suitable BRAF mutation (V600E) positive patients only.

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