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besponsa trial

besponsa trial

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besponsa trial
Welcome to BESPONSA® | BESPONSA®, About BESPONSA® | BESPONSA®, Drug Trials Snapshots: BESPONSA, Clinical Trial | BESPONSA™ (inotuzumab ozogamicin , Besponsa New FDA Drug Approval | CenterWatch, Besponsa (Inotuzumab Ozogamicin) | Lymphoma News Today, , , .
BESPONSA can cause liver problems that can be severe, life-threatening, or fatal, including a condition called veno-occlusive disease (VOD). This condition can occur during treatment with BESPONSA or following subsequent treatment with a stem cell transplant. This condition was more common in patients who had elevated liver tests or who received dual alkylating agents in preparation for their stem cell transplant. Patients may be at a higher risk of VOD if they: . The Food and Drug Administration approved BESPONSA based on the results of the clinical trial that showed treatment with BESPONSA compared to chemotherapy improved complete remission (CR) rates (36% vs 17%), length of CR (8.0 months vs 4.9 months), and minimal residual disease–negative CR rates (90% vs 32%).. BESPONSA was evaluated versus chemotherapy in a large, global clinical trial in 326 adults with relapsed or refractory ALL BESPONSA was studied in patients who were Philadelphia chromosome (Ph)–positive or Ph–negative in first or second relapse, or who were refractory to their previous treatment.
The safety and efficacy of BESPONSA were established in one active-controlled, randomized (1:1), open label, multicenter trial in patients with relapsed or refractory ALL. Patients were ≥ 18 . The efficacy of BESPONSA was established on the basis of CR, duration of CR, and proportion of MRD-negative CR in the first 218 patients randomized. Besponsa (inotuzumab ozogamicin): For the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. New approved drug details including side effects, uses and general information.. Besponsa (inotuzumab ozogamicin, previously CMC-544) is an approved therapy developed by Pfizer to treat adults with B-cell precursor acute lymphoblastic leukemia (ALL) whose disease has relapsed or who did not respond to standard therapy.. . .
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