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Monthly News Round Up - August 2012

Xtandi Receives Priority Review Approval for Late Stage Prostate Cancer

Roughly 28,000 men will die from prostate cancer in 2012. The U.S. Food and Drug Administration (FDA) has approved Xtandi (enzalutamide) under priority review for late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi is approved for patients previously treated with the anti-cancer agent docetaxel. In clinical trials, Xtandi extended the median survival for patients by 18.4 months compared to 13.6 months for patients who received a placebo. In studies, seizures occurred in approximately one percent of patients receiving Xtandi, who then had to stop treatment. The safety of Xtandi in patients with a risk for seizures is unknown.

Linzess Approved for Treatment of Chronic and IBS-Related Constipation

Constipation is a common U.S. problem, with over 78 million people suffering from chronic constipation or irritable bowel syndrome with constipation (IBS-C). Once-daily Linzess (linaclotide) capsules have been approved by the U.S. Food and Drug Administration to offer relief to patients with these types of constipation. Linzess has been shown to activate intestinal chloride channels to increase fluid secretion and facilitate bowel movements. The Linzess approved labeling states the drug should not be used in patients less than 17 years of age. The most common side effect reported in studies was diarrhea. Amitiza is another option also approved for chronic constipation and IBS-C.

Afinitor Disperz Approved for Rare Pediatric Cancer

The anti-cancer agent Afinitor Disperz (everolimus tablets for oral suspension) has been approved for children aged one and older who have tuberous sclerosis complex (TSC) and an accompanying rare brain tumor, subependymal giant cell astrocytoma (SEGA), that cannot be treated with surgery. TSC is a rare genetic disease that leads to tumors in the brain and other key organs. Afinitor Disperz is dissolved in a small amount of water prior to administration to ease dosing in children who are unable to swallow tablets. The most common side effects observed during clinical trials were mouth ulcers and respiratory infections.

Zaltrap Approved for Metastatic Colorectal Cancer

Over 50,000 patients will die from colorectal cancer in 2012, the fourth leading cause of cancer death. The U.S. Food and Drug Administration has approved Zaltrap (ziv-aflibercept), an angiogenesis inhibitor to be used in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Zaltrap extended overall survival in roughly 1200 patients with mCRC whose cancer grew despite receiving oxaliplatin-based chemotherapy. Patients receiving Zaltrap plus FOLFIRI lived on average 13.5 months compared to 12 months for patients on placebo plus FOLFIRI.

Four-Drug Combo Approved for HIV Treatment

The U.S. Food and Drug Administration has approved Gilead’s once-a-day Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) to treat HIV-1 infection in adults who have not previously received HIV treatment. Stribild contains two previously approved HIV drugs - emtricitabine and tenofovir plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor that interferes with a required enzyme. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs; it is used to prolong the effect of elvitegravir. Two clinical studies found that roughly 90 percent of patients treated with Stribild had undetectable levels of HIV in their blood after 48 weeks of treatment. Stribild had previously been referred to as the “Quad”.

Posted: August 2012