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besponsa orphan

besponsa orphan

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besponsa orphan
Besponsa | European Medicines Agency, inotuzumab ozogamicin (Besponsa) - scottishmedicines.org.uk, FDA approves new treatment for adults with relapsed or , EU/3/13/1127 | European Medicines Agency, Besponsa: Uses, Side Effects, Benefits/Risks | Drugs.com, NICE set to reject Pfizer's leukaemia drug Besponsa - PMLiVE, , , .
The safety and efficacy of Besponsa were studied in a randomized trial of 326 patients with relapsed or refractory B-cell ALL who had received one or two prior treatments. Patients were randomized to receive treatment with Besponsa or an alternative chemotherapy regimen. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR). Of the 218 evaluated patients, 35.8 percent who received Besponsa experienced CR for a median 8.0 months; of the patients who received alternative chemotherapy, 17.4 percent experienced CR for a median 4.9 months.. Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare’, and Besponsa was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 7 June 2013.. following a full submission assessed under the ultra-orphan and end of life medicine process: inotuzumab ozogamicin (BESPONSA®) is accepted for restricted use within NHSScotland. Indication under review: as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL)..
Release. The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment,. On 7 June 2013, orphan designation (EU/3/13/1127) was granted by the European Commission to Pfizer Limited, United Kingdom, for inotuzumab ozogamicin for the treatment of B-cell acute lymphoblastic leukaemia. Inotuzumab ozogamicin has been authorised in the EU as Besponsa since 29 June 2017.. Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare’, and Besponsa was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 7 June 2013.. The National Institute of Healthcare and Excellence (NICE) is set to reject Pfizer’s orphan drug for leukaemia Besponsa (inotuzumab ozogamicin). Pfizer issued a robust defence of its product, saying the UK cost-effectiveness watchdog’s final appraisal determination had ‘inappropriately’ assessed the drug’s value.. . .
 
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