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Shift Toward Chemotherapy-Free Approaches Redefines Upfront CLL Treatment Selection
07 Aug 2025 02:41 GMT
… (NCT02475681) trials, Dorritie noted. In the AMPLIFY trial, at … also highlighted differences in treatment strategies for patients with … University of Pittsburgh Medical Center Hillman Cancer … , cyclophosphamide, and rituximab [Rituxan], for example, or even …
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ALPHA3 Trial of Cema-Cel in LBCL Proceeds With Fludarabine/Cyclophosphamide Lymphodepletion Regimen
04 Aug 2025 19:46 GMT
… the FDA.
Moreover, the arm of the trial evaluating … have arisen in clinical trials initiated by Allogene … study treatment and has the potential to accelerate trial enrollment … as R-CHOP (rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine, and …
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FDA Issues CRL for Odronextamab in Relapsed/Refractory Follicular Lymphoma
01 Aug 2025 16:15 GMT
… trials.
Notably, the confirmatory phase 3 OLYMPIA-1 trial … be ineligible for treatment with rituximab (Rituxan)/lenalidomide … odronextamab-bla-accepted-fda-review-treatment
Ordspono (odronextamab) … . News release. Regeneron Pharmaceuticals, Inc. August 26, …
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FDA Issued Myeloma, Alzheimer’s Approvals in July but Rejected Two CGTs
31 Jul 2025 16:10 GMT
… -Demand HAE Pill
Drug: Ekterly
Decision: New drug approved
Date: … open-label KONFIDENT-S trial bolstered these findings, … disability.
According to the biotech, the rejection was … , Rituxan, cyclophosphamide, doxorubicin and prednisone for the treatment of …
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Celltrion closes in on US plant purchase, dubbing drug substance facility 'fundamental' to tariff mitigation
30 Jul 2025 19:59 GMT
… drug substances. It is based at “a major pharmaceutical … cancer and autoimmune disease treatments—for several years,” … drugs like Johnson & Johnson’s Remicade and Stelara, Roche’s Rituxan … threatened to impose pharmaceutical import tariffs, sometimes …
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sNDA Submitted to FDA for Venetoclax Plus Acalabrutinib in Untreated CLL
29 Jul 2025 20:43 GMT
… a supplemental new drug application for a fixed … trial published in the New England Journal of Medicine … #47;cyclophosphamide/rituximab (Rituxan) or bendamustine (Bendeka)… trials.
AbbVie submits for U.S. FDA approval of combination treatment …
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FDA Accepts BLA, Grants Priority Review to Tab-Cel in EBV-Positive PTLD
29 Jul 2025 00:10 GMT
… Pharmaceuticals (PFP).1
The FDA has set a Prescription Drug … results from the trial supported the FDA’s decision. Updated … PTLD have no approved FDA treatment options, and following failure … 47;refractory to rituximab (Rituxan) following prior allogeneic HSCT …
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Top Trials From the 2025 ASCO and EHA Meetings
25 Jul 2025 18:56 GMT
… detectable ESR1 mutations.5 These trials evaluated therapies for a … investigational trispecific antibody for the treatment of relapsed/refractory multiple … 3 POLARGO trial (NCT04182204) of polatuzumab vedotin (Polivy), rituximab (Rituxan), gemcitabine, …
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Generic Ibrutinib Tablet Given Tentative FDA Approval in CLL/SLL, WM
25 Jul 2025 19:04 GMT
… and 5 randomized, controlled trials, including the RESTONATE trial (NCT01578707).3 RESONATE … placebo, in combination with rituximab (Rituxan). Treatment with ibrutinib lessened the risk … ://www.accessdata.fda.gov/drugsatfda_docs/appletter…
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FDA Accepts Tabelecleucel BLA; Priority Review Granted for Post-Transplant Disease Therapy
25 Jul 2025 04:27 GMT
… release. A Prescription Drug User Fee Act (PDUFA … FDA has also granted tab-cel Breakthrough Therapy Designation for the treatment … with the Pierre Fabre Pharmaceuticals team to help … higher doses of immunosuppression medications to prevent transplant rejection …