New FDA Approvals

These drugs were recently approved by the FDA:

Anidulafungin (Eraxis) by Pfizer. The FDA has approved anidulafungin (Eraxis) to treat certain infections caused by Candida, a yeast-like fungus that can cause serious infections in hospitalized patients or patients with compromised immune systems.

Anidulafungin, a new molecular entity that has never been marketed in the United States, is an antifungal drug that is administered intravenously, and is used to treat Candida infections in the esophagus (candidiasis), bloodstream (candidemia), and other forms of Candida infections, including abdominal abscesses and peritonitis.

Anidulafungin was generally well tolerated in clinical studies. The most commonly reported adverse events were mild diarrhea, mild elevations in laboratory tests of liver enzymes, and headache. Some patients experienced infusion-related reactions, most of which were mild. In a few patients with significant underlying medical conditions who were on multiple concomitant medications, there were reports of serious hepatic abnormalities.

New indication for cetuximab (Erbitux), manufactured by ImClone Systems and distributed and marketed by Bristol-Myers Squibb Co. The FDA has approved cetuximab (Erbitux) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that cannot be removed by surgery (unresectable SCCHN). This is the first drug approved for head and neck cancer that has shown a survival benefit in this population. Cetuximab also was approved for monotherapy to treat patients whose head and neck cancer has metastasized despite the use of standard chemotherapy.

This is the second indicated tumor type for cetuximab, previously approved by the FDA for use in combination with irinotecan for patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer who are refractory to irinotecan therapy and as a single-agent for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan therapy.

Cetuximab, which received a priority review, is the first drug approved to treat head and neck cancer since methotrexate became available in the 1950s. Approval of cetuximab in combination with radiation therapy was based on a study that showed it prolonged survival by 20 months compared to treatment with radiation alone. Approval of cetuximab monotherapy was based on evidence of tumor shrinkage in 13% of patients, lasting on average of six months.

Commonly reported side effects of cetuximab were infusion reactions (fever, chills), skin rash, fatigue/malaise, and nausea. The common side effects associated with radiation such as sore mouth, trouble swallowing, and radiation skin changes were similar in frequency in patients receiving cetuximab plus radiation and those receiving radiation alone.

New indication for rituximab (Rituxan) by Genentech. The FDA has approved rituximab (Rituxan) for use in the first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma, in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. Rituximab previously has been approved as a single agent for use in relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL).

The approval was based on efficacy and safety data from three randomized, controlled, multicenter studies of rituximab in combination with CHOP or other anthracycline-based chemotherapy induction regimens in 1,854 previously untreated (first-line) patients with diffuse large B-cell lymphoma (DLBCL). In each study, hazard ratios for the time-to-event comparison, as well as the overall survival benefit, favored the rituximab-containing arms.