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Treatment of people aged twelve years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy [2]
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A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
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In February 2016, the US Food and Drug Administration (FDA) granted breakthrough therapy designation for primary progressive multiple sclerosis. [21] In March 2017, the FDA approved ocrelizumab for relapsing-remitting and primary-progressive multiple sclerosis. It is the first FDA-approved treatment for the primary progressive form.
Scientists have developed a new treatment that may help regenerate myelin around nerve cells, and potentially reverse the damage caused by multiple sclerosis (MS).
Multiple sclerosis is a disease that causes the immune system to attack the central nervous system, leading to communication problems between the brain and the rest of the body.
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