Image via WikipediaTWO TARGETED THERAPIES APPROVED: XALKORI AND ZELBORAF FOR AGGRESSIVE CANCERS
Two advanced cancer treatments with accompanying diagnostic genetic tests have been approved this month. Xalkori (crizotinib), with the Vysis ALK Break Apart FISH Probe Kit wasapproved to 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 also approvedto treat BRAF V600E mutation-positive, inoperable or metastatic melanoma. Zelboraf’s companion diagnostic test is the cobas 4800 BRAF V600 Mutation Test. In the most recent clinical trials, the median overall survival with Zelboraf had not been reached, and 77% of patients were still living. Research into molecular targeted therapies, such as Xalkori and Zelboraf, are an increasing trend in oncology research.FDA Approves Firazyr (icatibant) for Acute Attacks of Hereditary Angioedema
Firazyr (icatibant), a selective B2 bradykinin receptor antagonist, has been FDA-approved foracute 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 hereditary angioedema (HAE) often require a patient to travel to the hospital or clinic for treatment. 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 avoid abrupt trips for treatment.
Adcetris Approved For Lymphoma Treatment After Accelerated FDA Review
A new treatment for Hodgkin lymphoma has not been approved in over three decades. But this month the FDA approved Adcetris (brentuximab vedotin), an antibody-drug conjugate (ADC) for the treatment of relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). The attached antibody targets the drug to the CD30 site on lymphoma cells found in both HL and ALCL. In HL (n=102) and ALCL (n=58), 73% and 86% of patients, respectively, had a partial or complete response to Adcetris treatment. The FDA accelerated approval program can speed access to new drugs for serious illnesses.
Propel Medical Device Approved: Sinus Implant Releases Anti-inflammatory Drug
Chances are that you have had acute sinusitis that may occur after a bad cold. Symptoms may include nasal swelling and difficult breathing, cough, headache, pain behind the eyes, and loss of smell. For most patients, these symptoms will usually resolve over a period of 10 days. However, some patients develop chronic sinusitis, lasting longer than 8 to 12 weeks, and possibly recurring. A new medical device has been FDA-approved that, when inserted after endoscopic sinus surgery, locally delivers the anti-inflammatory mometasone to sinus tissue to help reduce scarring, and possibly the need for additional surgery. Propel, manufactured by Intersect ENT, Inc. will launch this fall.
New Once-A-Day HIV Treatment: Complera Wins Approval for Treatment-Naive Patients
Multiple daily doses of HIV medication can be inconvenient and may encourage noncompliance, which can lead to drug resistance. Complera, a once-a-day combination treatment has gainedFDA approval for use in HIV patients who have never received any prior HIV treatment (treatment-naive patients). Complera is composed of Gilead’s Truvada (emtricitabine/tenofovir) with Johnson and Johnson’s Edurant (rilpivirine). Complera is the second once-daily medication to be approved for treatment-naive HIV patients, after Atripla (efavirenz/emtricitabine/tenofovir). Gilead’s 4-drug combo, known as the Quad, is expected to be submitted for FDA approval in Q1 of 2012.
First Antidote Approved by the FDA to Treat Venomous Scorpion Stings
Arachnophobia? Join the crowd. But the FDA has approved a treatment that might help lessen our fears. Anascorp, the first antivenom specifically for the painful sting of the Centruroides scorpion (bark scorpion), the most common type of scorpion in the US, has been approved. In the US, venomous scorpions are mainly found in Arizona. The severe stings can be life-threatening, especially in infants and small children, and often require an ICU stay. One clinical trial in 15 children with Anascorp was impressive, with all 8 children who received the antidote gaining relief from neurological signs of the stings within 4 hours. Only 1 in 7 children who received placebo had similar relief. In total, more than 1500 patients were evaluated in Anascorp studies.
Posted: August 2011
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