FDA Approves Iressa for EGFR Metastatic Lung Cancer

“Iressa (gefitinib) has been approved by the U.S. Food and Drug Administration to treat patients with metastatic non-small-cell lung cancer (NSCLC) with a specific genetic mutation (epidermal growth factor receptor [EGFR]). A just-approved companion diagnostic test can identify patients who could benefit from this new use.

“Iressa is a kinase inhibitor, a class of drugs designed to block proteins that spur development of cancer cells. The therascreen EGFR RGQ PCR Kit is a newly approved diagnostic that can help doctors detect patients with the genetic mutation who are candidates for treatment with Iressa.

“Iressa was evaluated for this use in clinical trials involving 106 people with previously untreated EGFR mutation-positive metastatic NSCLC. Tumors shrank in about 50 percent of people treated with Iressa 250 mg once daily. This effect lasted an average of six months, the FDA said. Severe side effects of Iressa may include interstitial lung disease, liver damage, gastrointestinal perforation, severe diarrhea, and ocular disorders. More common side effects are diarrhea and skin reactions.”


Patients with Metastatic Melanoma Do Better with Immunotherapy Treatment before Zelboraf

The gist: In a clinical trial, patients with stage IV metastatic melanoma had better responses to treatment with vemurafenib (Zelboraf) if they received immunotherapy drugs beforehand than if they received chemotherapy or “kinase inhibitor” drugs beforehand.

“Prior treatment appeared to considerably affect how patients with stage IV metastatic melanoma responded to vemurafenib therapy, according to study results.

“Those who had undergone prior treatment with immunotherapy demonstrated better outcomes with vemurafenib (Zelboraf, Hoffmann-La Roche) than those who underwent prior treatment with chemotherapy or kinase inhibitors, results showed…

“ ‘Our data demonstrate that the type of pretreatment strongly influences the outcome of vemurafenib therapy, with a precedent immunotherapy showing a positive, and a prior chemotherapy and kinase inhibitors showing a negative impact on survival, respectively,’ Ugurel and colleagues wrote. ‘Moreover, we show that the patient’s overall performance status, serum LDH, age and gender independently impact vemurafenib therapy outcome. These findings should be taken into account for future design of therapy sequencing in BRAF V600 mutation-positive melanoma patients.’ ”