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Monthly Roundup - January 2012

Bydureon Approved: First Once-A-Week Treatment for Type 2 Diabetes

Amylin Pharmaceuticals received FDA-approval of Bydureon (exenatide extended-release for injectable suspension), a once-a-week, 2 mg injection used in conjunction with diet and exercise to improve glycemic control in type 2 diabetics. Exenatide is the same active ingredient in Byetta, which is given twice daily. The 24-week DURATION-5 clinical trial demonstrated that Bydureon statistically reduced A1C, a measure of blood sugar control, by 1.6 percentage points compared to a 0.9 percentage point reduction with Byetta. Nausea was the most frequently reported adverse event. A boxed warning of the occurrence of thyroid C-cell tumors at clinically relevant doses in rats accompanies the Bydureon approval; however, it is not known if Bydureon causes medullary thyroid carcinoma (MTC) in humans.

FDA Approves Picato Gel for Actinic Keratosis

Actinic keratosis (AK) is a precursor to squamous cell carcinoma, the second most common type of skin cancer. Picato (ingenol mebutate) Gel is now approved in a 0.015% strength for the face and scalp area to be used once daily for three consecutive days, or a 0.05% strength used once-daily for two consecutive days on the trunk and extremities. Picato is the first AK treatment with a short 2 or 3-day treatment duration. Placebo-controlled trials in over 1,000 patients with AK demonstrated significantly greater complete lesion clearance with Picato. The most common adverse effects were local skin reactions such as redness, flaking/scaling, crusting and swelling.

Erivedge Receives Priority Approval For Metastatic Skin Cancer

Basal cell carcinoma is the most common form of skin cancer due to sun damage. But when the cancer is no longer treatable by surgical or radiation measures, or the disease has spread in the body, approved treatments are limited. The U.S. Food and Drug Administration has approved Erivedge (vismodegib), the first hedgehog pathway inhibitor available for treatment of metastatic basal cell cancer. In Genentech trials, a partial response was seen in 30 percent of patients with metastatic disease, while a partial or complete response was seen in 43 percent of patients with locally advanced disease. The median duration of response was 7.6 months. Common side effects include muscle spasms, hair loss, altered taste and weight loss. Fetal defects or death may occur with Erivedge exposure in pregnancy.

Inlyta Approved For Advanced Renal Cell Carcinoma

Inlyta (axitinib) is an oral kinase inhibitor approved for the treatment of advanced renal cell carcinoma (kidney cancer) in adults after failure of one prior therapy. A single, randomized, open-label clinical trial (n=723) demonstrated that Inlyta resulted in a median progression-free survival of 6.7 months compared to 4.7 months with Nexavar (sorafenib), also a renal cell cancer drug. Common side effects include diarrhea, high blood pressure, and fatigue. High blood pressure should be well controlled in all patients prior to treatment. Avoid strong CYP3A4/5 inhibitors with Inlyta. Other approved agents for renal cell carcinoma include sunitinib, temsirolimus, everolimus, bevacizumab, and pazopanib.

Orphan Drug Approval: Voraxaze To Treat Methotrexate Toxicity

Methotrexate, used as a chemotherapeutic agent, is normally eliminated from the body by the kidneys. However, high doses and prolonged exposure of the drug may lead to kidney impairment. The U.S. Food and Drug Administration has approved Voraxaze (glucarpidase), an intravenous carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function. A clinical study evaluated Voraxaze in 22 patients, all of whom received the active drug. Ten of the 22 patients achieved the required reduced methotrexate levels within 15 minutes and maintained this level for eight days. Fusilev (levoleucovorin) is also approved as treatment for methotrexate toxicity.

Subsys Approved Under Restricted Access Program

Breakthrough cancer pain results in sudden, intense pain episodes that occur even though the patient is receiving continuous pain relief medication. Subsys (fentanyl sublingual spray) is now approved specifically for adult cancer patients with breakthrough pain who are opioid-tolerant and currently receiving around-the-clock opioid therapy. Subsys use is contraindicated in acute or post-operative pain, as fatal respiratory depression and death may occur in opioid non-tolerant patients. Combined use of moderate or strong CYP450 3A4 inhibitors can result in a drug interaction that may warrant a Subsys dose reduction to prevent severe respiratory depression. Use, prescribing, distribution and dispensing of Subsys requires enrollment in the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access Program.

Posted: January 2012