Expert opinion on biological therapy
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Expert Opin Biol Ther · Jan 2016
EditorialTotality of the evidence at work: The first U.S. biosimilar.
On March 6(th) 2015, the Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) as the first biosimilar in the United States (US) for all indications of the reference product. Filgrastim-sndz is a biosimilar of Amgen's Neupogen and is mainly used to treat neutropenia in cancer patients receiving chemotherapy. This article presents a summary of the analytical and clinical studies submitted by Sandoz and describes how the information was integrated to provide the 'totality of the evidence' leading to the approval of the biosimilar.
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Expert Opin Biol Ther · Jan 2016
ReviewThe role of tandem stem cell transplantation for multiple myeloma patients.
Autologous Stem Cell Transplantation (ASCT) represents the standard treatment in eligible "de-novo" multiple myeloma (MM) patients. ⋯ A tandem ASCT approach should be considered for all patients, although the benefit from the second ASCT in patients who are in complete remission or experience a very good partial response should be answered in a clinical trial. Recent results with the new induction regimens indicate that there is a role for tandem ASCT in the presence of adverse cytogenetic abnormalities. Planned AlloSCT after ASCT has not been found to be superior in the majority of studies and is not recommended outside of a clinical trial. However, single or tandem ASCT are both appropriate options and participation in prospective clinical trials should be encouraged to resolve the debate in the era of novel agents for MM.
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Expert Opin Biol Ther · Jan 2016
ReviewCell-based therapies for the treatment of idiopathic pulmonary fibrosis (IPF) disease.
During the last few decades, cell-based therapies have shown great potential to treat patients with lung diseases. It has been proposed that the administration of cells into an injured lung could be considered as a therapeutic method to repair and replace lost lung tissue. Using this method, transplanted cells with the ability to proliferate and differentiate into alveolar cells, have been suggested as a therapeutic strategy for IPF treatment. ⋯ After many years of investigation, the use of cell-based therapies to treat IPF is still at the experimental phase. Problems include bioethical issues, safety of cell transplantation, routes of delivery and the dose and timing of administration. Further investigations are necessary to establish the best strategy for using cell-based therapies effectively for the treatment of IPF.
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Cervical cancer is still a major cause of morbidity and mortality in women. Early stages and locally advanced cervical cancer are currently treated respectively with surgery and chemoradiation with good prognosis. Persistent, recurrent and metastatic cervical cancers have a poor prognosis. Angiogenesis has been identified as a crucial factor for cervical cancer growth. Recently, research has increasingly focused on the development of targeted therapies, such as anti-angiogenic drugs. Amongst such drugs, bevacizumab, a recombinant humanized monoclonal antibody has been the subject of extensive investigation, including its use in cervical cancer. This was recently approved for the treatment of patients with metastatic, recurrent, or persistent cervical cancer. ⋯ The use of bevacizumab in combination with other chemotherapies in cervical cancer has been proven safe and effective, with a significant improvement in overall survival of patients with advanced cervical cancer. Combination therapy using bevacizumab has been demonstrated to increase toxicity rates but it does not impair patient's quality of life.
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Successful healing of large bone defects (LBDs) is a complicated phenomenon because the body's natural ability often fails to effectively repair the LBDs. New modalities should be utilized to increase the quality and accelerate bone healing. Platelet concentrates in different forms can be considered an attractive option for such purpose. ⋯ As the efficacy of PRP is dependent on various factors, the outcome of PRP therapy is variable and unpredictable in orthopedic patients. Therefore, it is still too soon to suggest PRP as the first line treatment option in complicated bone injuries such as LBDs and nonunions. However, combination of PRP with natural and synthetic biomaterials can enhance the effectiveness of PRP.