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AbbVie and Genmab’s Epkinly shows outpatient viability in Phase II trial
04 Sep 2025 13:43 GMT
… as an outpatient treatment in a Phase II trial.
The Phase … the US Food and Drug Administration (FDA) in May 2023. … axicabtagene ciloleucel) and Roche’s MabThera (rituximab).
B-cell lymphoma … you deserve! The Clinical Trials Arena Excellence Awards celebrate …
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Outlook blindsided as FDA blocks wet AMD drug once again
28 Aug 2025 20:28 GMT
… , the FDA typically requires two positive pivotal trials to support … #39;s Avastin/MabThera) is only indicated for cancer … studies – have variations in drug concentration that could affect … first-line anti-VEGF treatments in Europe, with approximately …
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Roche and Genentech’s Lunsumio-Polivy shows promise in Phase III trial
23 Jun 2025 12:47 GMT
… compared the combination to MabThera/Rituxan (rituximab), … profiles of the individual trial medicines.
Lunsumio and Polivy … bispecific antibody and antibody-drug conjugate, which could … content on Pharmaceutical Technology (or Clinical Trials Arena) is …
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Mixed outcomes for pharma in big week for FDA adcomms
22 May 2025 11:49 GMT
… the phase 3 AQUILA trial of the drug, which showed a progression … the New England Journal of Medicine.
HR-SMM is a … months without any active treatment. If the FDA approves Darzalex Faspro for … 's anti-CD20 antibody MabThera/Rituxan (rituximab) plus …
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FDA Panel Votes Against Columvi-GemOx sBLA for R/R DLBCL Over Regional Data Concerns from STARGLO Trial
21 May 2025 23:06 GMT
… STARGLO trial (NCT04408638), the FDA’s Oncologic Drugs Advisory Committee … PhD, Roche chief medical officer and head of … trial compared the efficacy and safety of Columvi plus GemOx versus MabThera … effective, readily available treatment options and the …
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Roche provides update on US FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory DLBCL
22 May 2025 06:32 GMT
… US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee ( … randomised, multiregional clinical trial, supporting its recent … with other medicines for the treatment of diffuse … Polivy (polatuzumab vedotin) and MabThera/Rituxan (rituximab), …
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EU Approves Roche’s Columvi as First Bispecific Antibody for DLBCL After Initial Treatment
16 Apr 2025 16:40 GMT
… overall survival (OS) improvement versus MabThera/Rituxan (rituximab) and GemOx … treatment advances have been made, challenges with the accessibility of existing medicines … offers an ‘’off-the-shelf’’ treatment regimen, readily available for infusion …
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Approval moves Columvi earlier in DLBCL treatment pathway
14 Apr 2025 12:25 GMT
… 's anti-CD20 antibody MabThera/Rituxan (rituximab) plus chemo … cell transplant (ASCT). The US FDA is due to make a … running the Epcore DLBCL-4 trial, which is testing Epkinly plus … is that its drug uses a fixed duration of treatment, while AbbVie …
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EMA Gives Positive Opinion to Lilly Treatment for Chronic Lymphocytic Leukemia
04 Mar 2025 00:07 GMT
… positive opinion by the European Medicines Agency (EMA)’s Committee … Jaypirca was one of 16 drugs for which CHMP extended therapeutic … in a randomized Phase III trial in this patient population, … , for treatment of not only CLL but also rheumatoid arthritis, in …
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EMA human medicine committee recommends approval of Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
03 Mar 2025 20:16 GMT
… with Polivy (polatuzumab vedotin) and MabThera/Rituxan, cyclophosphamide, doxorubicin and … gemcitabine plus oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination … in combination with other medicines for the treatment of diffuse large B …