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Weekly News Round Up - August 31, 2011

Targeted Therapy Approved: Xalkori for Aggressive Non-Small Cell Lung Cancers

Xalkori (crizotinib) FDA-approved with companion diagnostic test to treat aggressive lung cancer that expresses abnormal gene Read More...

Another advanced cancer treatment with a companion diagnostic genetic test has been approved. In addition to Zelboraf (vemurafenib) earlier in the month, the FDA okayed Xalkori (crizotinib) in the last week of August. Xalkori was approved with the Vysis ALK Break Apart FISH Probe Kit to diagnose and treat advanced or metastatic, non-small cell lung cancers (NSCLC) that express the abnormal anaplastic lymphoma kinase (ALK) gene. Xalkori response rates have ranged from 50-61% with median response durations of 42-48 weeks. Zelboraf (vemurafenib) was approved earlier in August to treat BRAF V600E mutation-positive, inoperable or metastatic melanoma.

FDA Approves Firazyr (icatibant) for Acute Attacks of Hereditary Angioedema

Firazyr approved: New treatment allows patients to self-inject potentially life-saving treatment for acute hereditary angioedema Read More...

New medications that also make your life more convenient are a great plus. Firazyr (icatibant), a selective B2 bradykinin receptor antagonist, has been FDA-approved for acute hereditary angioedema (HAE), a rare, genetic disorder.  HAE can cause unpredictable and potentially life-threatening swelling of the face, airways, and intestinal tract. Laryngeal attacks can be fatal due to closure of the airways and possible suffocation. Acute attacks of HAE often require a patient to travel to the hospital or clinic for treatment. However, Firazyr is available in a pre-filled syringe - patients can carry their treatment without refrigeration and inject the medicine themselves. Self-injection may require patient training, but will allow more freedom in work, school, and family life and help to avoid unscheduled trips for treatment.

Study Results: Experimental Agent Apixaban Superior to Warfarin for Prevention of Stroke or Systemic Embolism in Atrial Fibrillation

Direct Factor Xa inhibitor apixaban studied in 39 countries in over 18,000 patients with atrial fibrillation and at least one risk factor for stroke Read More...

Warfarin, a labor-intensive anticoagulant used for over half a century has some major competition brewing for prevention of stroke or systemic embolism. Phase 3 study results from ARISTOTLE were released this week and show that oral apixaban (Eliquis) was superior to warfarin for the reduction of stroke or systemic embolism in patients with atrial fibrillation. The risk of stroke or systemic embolism was reduced by 21%, major bleeding was reduced by 31%, and mortality decreased by 11% compared to warfarin. Additionally, apixaban does not require dose adjustments or regular blood tests like warfarin.

More Data Required: NuPathe’s Sumatriptan Patch for Migraine (Zelrix) Gets FDA Response

Migraine patch shown effective in overall population, but safety, manufacturing issues remain Read More...

The patch dosage form of sumatriptan for migraine treatment (Zelrix) will not be available for marketing until the second half of 2012, according to sponsor NuPathe, Inc. The Zelrix patch has been studied to treat migraine-related pain, nausea, and light sensitivity. Zelrix utilizes iontophoresis, a proprietary transdermal delivery mechanism, to rapidly deliver medication via a mild electric current. The complete response letter sent to NuPathe by the FDA this week outlined several areas where questions still remain, including safety, manufacturing and chemistry issues. However, the FDA did note that the migraine efficacy parameters were met in the overall population. NuPathe plans on addressing these questions to support FDA approval.

FDA Report: Cancer Drug Shortages Critical and May Be Life-Threatening

Some treatments in short supply may not have alternatives; drug shortages could be life-threatening Read More...

You always expect that the medication you need will be there. But, drug shortages for the most vulnerable of patients, those with life-threatening cancers, are on the rise. The FDA has been monitoring shortages for 6 years and is seeing a lack of older, sterile injectable drugs. Reasons for drugs shortfalls are varied, but may be due to increased demand, problems with raw materials, drug discontinuation, or misprints in drug packaging. Anesthetic agents and nutritional products are other products with supply issues. Some drugs in low supply may not have good substitutes, such as cytarabine for acute leukemia and cisplatin for testicular cancer. If the FDA deems a drug in short-supply is medically necessary, they will attempt to find suitable replacements.