Recent FDA approvals and indications (through June 2008) related to Rotarix, Pantanase, Treximet, Aplenzin, Relistor, Actonel, Vyvanse, Advair Diskus 250/50, and Orencia.
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New indication: Lubiprostone (Amitiza), a chloride channel activator, was approved on April 29, 2008, for the treatment of irritable bowel syndrome with constipation (IBS-C) in women aged at least 18 years.
New biologic: Certolizumab pegol (Cimzia), a tumor necrosis factor blocker, was approved on April 22, 2008, for the reduction of the signs and symptoms of Crohn's disease and the maintenance of clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
An RNA signature present in blood that is highly accurate for detecting prevalent lung cancer can accurately predict the development of lung cancer within the next 2 years 80% of the time, said Thomas Zander, MD, Department of Internal Medicine and the Center for Integrated Oncology, University Clinic Cologne, Germany. "Early detection of lung cancer is a major need, as most patients present for diagnosis at a late stage when there is no chance for cure," Dr Zander said. Two-year survival after a lung cancer diagnosis is approximately 15%. Early detection may therefore be a promising strategy to improve survival rates.
A small study suggests that acupuncture has the potential to reduce pain and dysfunction in patients with head and neck cancer who have undergone neck dissection, said David G. Pfister, MD, chief, Head and Neck Medical Oncology, Memorial Sloan Kettering Cancer Center, New York.
High-dose vitamin D supplementation can provide relief of symptoms related to vitamin D deficiency from aromatase inhibitor therapy in postmenopausal women with breast cancer, said Q.J. Khan, MD, Cancer Center of Kansas, Wichita.
Most elderly patients do not receive combined modality treatment (CMT) with both chemotherapy and radiation for locally advanced, non-small cell lung cancer (NSCLC) despite trial data indicating that CMT enhances survival, decreases comorbidities, and is potentially curative. Data presented by Martin J. Edelman, MD, professor of medicine, University of Maryland Greenebaum Cancer Center, Baltimore, indicate that elderly patients receiving chemotherapy followed by concurrent chemotherapy and radiation derive the most significant survival benefit.
Strict evidence-based criteria should be used when prescribing erythropoiesis-stimulating agents (ESAs) for cancer, as ESAs appear to activate signaling pathways that are important in altering tumor behavior and treatment response, experts said.
The extent to which patients should have access to experimental therapies is a hotly contested issue, and courts and regulatory agencies have wrestled with the problems involved when an individual is willing to be treated with unapproved drugs at the potential expense of causing harm not only to the individual but to the clinical trial process itself.
Drug-drug and disease-drug interactions in elderly patients with cancer are significant; 33% of elderly patients who are taking 3 or more medications are rehospitalized within 6 months of a hospital discharge. "A better index of predicting tolerance to chemotherapy in the elderly is crucial," said Mihaela Popa, MD, Moffitt Cancer Center, Tampa, Florida. Tolerance to chemotherapy among older patients with cancer may be affected by multiple chronic conditions requiring multiple medications and aging-related alterations that induce changes in drug distribution, she said.
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Patients with metastatic colorectal cancer are more likely to respond to initial treatment that includes cetuximab if they have nonmutated, wild-type KRAS gene status, reported Eric Van Cutsem, MD, University Hospital Gasthuisberg, Leuven, Belgium. "For the first time in colorectal cancer, we are able to predict which patients are likely to be helped by the new biologics," he said. "KRAS is the first molecular marker for the selection of a targeted therapy in combination with a standard chemotherapy regimen in first-line metastatic colorectal cancer. KRAS testing should be routinely conducted in all colorectal cancer patients immediately after diagnosis to ensure the best treatment strategies for the individual patient."
Drugs in development for the treatment of bipolar disorder and psychosis
Adding zoledronic acid to anastrozole or tamoxifen therapy decreased recurrence by 35% and increased disease free survival by 36% in premenopausal breast cancer patients, according to results of the Austrian Breast and Colorectal Cancer Study Group Trial 12 (ABCSG-12). The multicenter, Phase III trial is the first large trial to demonstrate the significant antitumor benefit of zoledronic acid, said Michael Gnant, MD, Medical University of Vienna. "Adjuvant treatment with zoledronic acid should be considered in order to improve the standard of care in premenopausal breast cancer patients," he said.
Modafinil appears to reduce the severity of chemotherapy-induced severe fatigue, reported Gary R. Morrow, PhD, MS.
Vaginal brachytherapy is as effective as external beam radiation therapy in preventing the recurrence of higher-risk endometrial cancer but with fewer side effects and results in superior quality of life, according to a Phase 3 study presented by Remi A. Nout, MD.
Adherence to a four-point Individualized Sleep Promotion Plan (ISPP) intervention consisting of stimulus control, sleep restriction, relaxation therapy, and sleep-hygiene practices significantly lowered fatigue and increased sleep quality for patients undergoing adjuvant chemotherapy. Fatigue and sleep disturbances are the most frequently reported symptoms during adjuvant chemotherapy for breast cancer. One-third of breast cancer patients report persistent fatigue and abnormal sleep/wake cycles, said Ann M Berger, PhD, RN, professor, College of Nursing, University of Nebraska Medical Center, Omaha.
Routine cardiac monitoring is suggested for patients receiving sunitinib, as cardiotoxicity, particularly left ventricular (LV) dysfunction, is common, said Melinda Telli, MD.
Everolimus, an experimental oral agent that targets the mTOR protein, may represent an effective second-line option for patients with metastatic renal-cell carcinoma whose disease has progressed despite treatment with a tyrosine kinase inhibitor.
Phase 3 trial results show that adding bevacizumab to docetaxel as first-line therapy for newly diagnosed HER2-negative, locally recurrent, or metastatic breast cancer resulted in significantly less disease progression. "This shows that the antiangiogenic approach to treating breast cancer is effective, regardless of which taxane drug it is combined with," said lead author David Miles, MD, professor, Mount Vernon Cancer Center, Middlesex, UK. Previous studies have shown that the combination of bevacizumab to paclitaxel doubled progression-free survival among patients with metastatic breast cancer.
Cancer is an independent predictor of increased vulnerability, functional limitations, geriatric syndromes, frailty, and fair or poor health status among older Medicare beneficiaries. "Up until now, a lot of this has been more opinion rather than numbers," said Gary R. Morrow, MD, professor of radiation oncology, University of Rochester Cancer Center. "This gives us a method to let us know if we have changed anything.
Live daily coverage beginning June 1 from the ASCO meeting in Chicago.
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Istradefylline, a highly selective adenosine A2A receptor antagonist, is a new agent being investigated for the adjunctive treatment of the motor signs and symptoms of idiopathic Parkinson disease.
Treatment options for osteoporosis include calcium, vitamin D, estrogen plus progesterone, calcitonin, and bisphosphonates.
Generic drugs approved by FDA (through May 2008) including amifostine for injection, clobetasol foam, granisetron oral solution, calcium acetate capsules, and irinotecan injection.
Recent FDA action (through May 2008) related to ceftobiprole, sugammadex, romiplostim, Gardasil, and amrubicin.
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