Edited Jame Abraham

Dabrafenib was recently approved by the US Food and Drug Administration for treatment of unresectable or metastatic melanoma with BRAF V600E mutations as detected by an FDA-approved test. The THxID BRAF assay, for detection of BRAF V600E mutations was concurrently approved. Dabrafenib is not indicated for the treatment of patients with wild-type BRAF melanoma, because of the potential risk of tumor promotion. About 50% of melanomas have an activating mutation in the BRAF gene, with about 80%-90% of those having a V600E mutation, and 10%-20% having a V600K mutation.

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Dabrafenib was recently approved by the US Food and Drug Administration for treatment of unresectable or metastatic melanoma with BRAF V600E mutations as detected by an FDA-approved test. The THxID BRAF assay, for detection of BRAF V600E mutations was concurrently approved. Dabrafenib is not indicated for the treatment of patients with wild-type BRAF melanoma, because of the potential risk of tumor promotion. About 50% of melanomas have an activating mutation in the BRAF gene, with about 80%-90% of those having a V600E mutation, and 10%-20% having a V600K mutation.

Click on the PDF icon at the top of this introduction to read the full article.

Dabrafenib was recently approved by the US Food and Drug Administration for treatment of unresectable or metastatic melanoma with BRAF V600E mutations as detected by an FDA-approved test. The THxID BRAF assay, for detection of BRAF V600E mutations was concurrently approved. Dabrafenib is not indicated for the treatment of patients with wild-type BRAF melanoma, because of the potential risk of tumor promotion. About 50% of melanomas have an activating mutation in the BRAF gene, with about 80%-90% of those having a V600E mutation, and 10%-20% having a V600K mutation.

Click on the PDF icon at the top of this introduction to read the full article.

In July 2013, afatinib was approved by the US Food and Drug Administration for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Quiagen’s therascreen EGFR RGQ PCR Kit for detection of EGFR exon 19 deletions (del19) and exon 21 (L858R) substitution mutations was concurrently approved. Afatinib is an oral selective ErbB family inhibitor that irreversibly blocks signaling from EGFR/ErbB1, HER2/ErbB2, and ErbB4 and has shown broad-spectrum activity against tumor cells with EGFR mutations.

Click on the PDF icon at the top of this introduction to read the full article.

In July 2013, afatinib was approved by the US Food and Drug Administration for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Quiagen’s therascreen EGFR RGQ PCR Kit for detection of EGFR exon 19 deletions (del19) and exon 21 (L858R) substitution mutations was concurrently approved. Afatinib is an oral selective ErbB family inhibitor that irreversibly blocks signaling from EGFR/ErbB1, HER2/ErbB2, and ErbB4 and has shown broad-spectrum activity against tumor cells with EGFR mutations.

Click on the PDF icon at the top of this introduction to read the full article.

In July 2013, afatinib was approved by the US Food and Drug Administration for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Quiagen’s therascreen EGFR RGQ PCR Kit for detection of EGFR exon 19 deletions (del19) and exon 21 (L858R) substitution mutations was concurrently approved. Afatinib is an oral selective ErbB family inhibitor that irreversibly blocks signaling from EGFR/ErbB1, HER2/ErbB2, and ErbB4 and has shown broad-spectrum activity against tumor cells with EGFR mutations.

Click on the PDF icon at the top of this introduction to read the full article.