Report Prepared Matt Stenger

On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.^1,2 Approval of the combination is based on durable response rate observed in an open-label study.^2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

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

On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.^1,2 Approval of the combination is based on durable response rate observed in an open-label study.^2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

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

On January 9, 2014, the combination of trametinib and dabrafenib was granted accelerated approval by the US Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.^1,2 Approval of the combination is based on durable response rate observed in an open-label study.^2,3 Improvements in disease-related symptoms and overall survival have not yet been demonstrated for the combination. Both drugs were approved for use as single agents in this setting in May 2013.

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

On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

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

On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

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

On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.  
 

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

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.¹ The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.^2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

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

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.¹ The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.^2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

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

Pertuzumab injection was granted accelerated approval by the US Food and Drug Administration last fall for use in combination with trastuzumab plus docetaxel for neoadjuvant treatment of patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (either > 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer.¹ The accelerated approval was based on improvement in pathologic complete response (pCR) rate in a phase 2 trial.^2,3 Data showing improved event-free survival or overall survival are not yet available. Continued approval for this indication is contingent on demonstration of improvement in disease-free survival in a confirmatory trial.

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.

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.