Edited Jame Abraham, MD, FACP

In July 2012, cetuximab was approved for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC) as determined by Food and Drug Administration-approved tests. A companion diagnostic, Therascreen KRAS RGQ PCR Kit for determining KRAS mutation status was approved concurrently with the cetuximab approval. The test is a real-time polymerase chain reaction assay that detects 7 mutations of the KRAS gene; tumors with none of these mutations are considered wild-type KRAS tumors.

*For PDFs of the full article and accompanying Commentary, click on the links to the left of this introduction.

In July 2012, cetuximab was approved for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC) as determined by Food and Drug Administration-approved tests. A companion diagnostic, Therascreen KRAS RGQ PCR Kit for determining KRAS mutation status was approved concurrently with the cetuximab approval. The test is a real-time polymerase chain reaction assay that detects 7 mutations of the KRAS gene; tumors with none of these mutations are considered wild-type KRAS tumors.

*For PDFs of the full article and accompanying Commentary, click on the links to the left of this introduction.

In July 2012, cetuximab was approved for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC) as determined by Food and Drug Administration-approved tests. A companion diagnostic, Therascreen KRAS RGQ PCR Kit for determining KRAS mutation status was approved concurrently with the cetuximab approval. The test is a real-time polymerase chain reaction assay that detects 7 mutations of the KRAS gene; tumors with none of these mutations are considered wild-type KRAS tumors.

*For PDFs of the full article and accompanying Commentary, click on the links to the left of this introduction.

In July 2012, carfilzomib was given accelerated approval by the Food and Drug Administration for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and have exhibited disease progression during or within 60 days of completing their last therapy. The approval was based on results of a single-arm, multicenter phase 2 trial of carfilzomib in patients with relapsed and refractory MM. As a condition of the accelerated approval, the manufacturer of the drug has to submit a final analysis of an ongoing phase 3 trial that compares carfilzomib plus lenalidomide plus low-dose dexamethasone with lenalidomide plus low-dose dexamethasone in patients with relapsed and refractory MM after 1 to 3 previous therapies. The primary end point of this trial is progression-free survival (PFS)...

*For a PDF of the full article and accompanying Commentaries, click on the links to the left of this introduction.

In July 2012, carfilzomib was given accelerated approval by the Food and Drug Administration for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and have exhibited disease progression during or within 60 days of completing their last therapy. The approval was based on results of a single-arm, multicenter phase 2 trial of carfilzomib in patients with relapsed and refractory MM. As a condition of the accelerated approval, the manufacturer of the drug has to submit a final analysis of an ongoing phase 3 trial that compares carfilzomib plus lenalidomide plus low-dose dexamethasone with lenalidomide plus low-dose dexamethasone in patients with relapsed and refractory MM after 1 to 3 previous therapies. The primary end point of this trial is progression-free survival (PFS)...

*For a PDF of the full article and accompanying Commentaries, click on the links to the left of this introduction.

In July 2012, carfilzomib was given accelerated approval by the Food and Drug Administration for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior therapies including bortezomib and an immunomodulatory agent and have exhibited disease progression during or within 60 days of completing their last therapy. The approval was based on results of a single-arm, multicenter phase 2 trial of carfilzomib in patients with relapsed and refractory MM. As a condition of the accelerated approval, the manufacturer of the drug has to submit a final analysis of an ongoing phase 3 trial that compares carfilzomib plus lenalidomide plus low-dose dexamethasone with lenalidomide plus low-dose dexamethasone in patients with relapsed and refractory MM after 1 to 3 previous therapies. The primary end point of this trial is progression-free survival (PFS)...

*For a PDF of the full article and accompanying Commentaries, click on the links to the left of this introduction.