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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]
Multiple sclerosis (MS) is an autoimmune disorder in which the immune system attacks and destroys the myelin sheath of nerve cells. It most commonly strikes people between the ages of 20 and 40.
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 ...
Interferon beta-1a (also interferon beta 1-alpha) is a cytokine in the interferon family used to treat multiple sclerosis (MS). [5] It is produced by mammalian cells, while interferon beta-1b is produced in modified E. coli. [6] Some research indicates that interferon injections may result in an 18–38% reduction in the rate of MS relapses. [7]
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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.
In March 2017, ocrelizumab was approved in the United States for the treatment of primary progressive multiple sclerosis in adults. [22] [42] It is also used for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. [42]