New FDA Approvals

These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):

Bevacizumab (Avastin ) by Genentech. The FDA has approved bevacizumab (Avastin) as a first-line treatment for patients with metastatic colorectal cancer.

Bevacizumab, a monoclonal antibody, is the first angiogenesis inhibitor to be approved. Bevacizumab was shown to extend patients’ lives by about five months when given intravenously as a combination treatment along with standard chemotherapy drugs for colon cancer (the "Saltz regimen," also known as IFL). IFL treatment includes ironotecan, 5-fluorouracil, and leucovorin.

Serious, but uncommon, side effects of bevacizumab include formation of holes in the colon generally requiring surgery and sometimes leading to intra-abdominal infections, impaired wound healing, and bleeding from the lungs or internally. Other, more common side effects are high blood pressure, fatigue, blood clots, diarrhea, decreased white blood cells (lowering immunity to diseases) headache, appetite loss, and mouth sores.

Pemetrexed disodium (Alimta) by Eli Lilly & Co. The FDA has approved pemetrexed disodium (Alimta) for use in combination with cisplatin for the treatment of patients with malignant pleural mesothelioma. Pemetrexed disodium received a priority review and is designated as an orphan drug. It is the first drug approved for this condition.

The effectiveness of pemetrexed disodium was established in one randomized clinical trial comparing the effects of treatment with pemetrexed disodium given with cisplatin to treatment with cisplatin alone. Patients receiving pemetrexed disodium and cisplatin lived three months longer after randomization than patients given cisplatin alone (12 months vs. nine months). Pemetrexed disodium must be administered with vitamin B12 and folic acid supplementation to decrease the incidence and severity of adverse effects.

The most common adverse reactions observed with use of pemetrexed disodium are low white blood count, nausea, vomiting, fatigue, rash, and diarrhea. Patients and caregivers should be encouraged to report the onset of fever, chills, diarrhea, and mouth ulcers immediately, since these symptoms could be a sign of infection, resulting from bone marrow suppression by the drug.

Cetuximab (Erbitux), manufactured by ImClone Systems and distributed by Bristol-Myers Squibb Co. The FDA has approved cetuximab (Erbitux) to treat patients with advanced colorectal cancer that has spread to other parts of the body. Cetuximab is the first monoclonal antibody approved to treat this type of cancer and is indicated as a combination treatment to be given intravenously with irinotecan, another drug approved to fight colorectal cancer, or alone if patients cannot tolerate irinotecan.

Cetuximab was approved under the FDA’s accelerated approval program. Although treatment with cetuximab has not been shown to extend patients’ lives, it was shown to shrink tumors in some patients and delay tumor growth, especially when used as a combination treatment.

Cetuximab can cause serious side effects, usually during the administration of the first treatment, which may include difficulty breathing and low blood pressure. Infrequent interstitial lung disease (ILD) has been reported; however, it is difficult to determine if cetuximab caused ILD. Other more common side effects of cetuximab treatment include acne-like rash, dry skin, tiredness or weakness, fever, constipation, and abdominal pain.

The FDA also approved a test kit, manufactured by DakoCytomation California that is used by doctors to analyze a colon tissue sample. The kit detects a protein in the body (HER-1) that stimulates cancerous tissue cell growth. Presence of this protein indicates that a patient is eligible for colon cancer treatment with cetuximab.