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FDA Issues CRL to Odronextamab in Pretreated Follicular Lymphoma
04 Aug 2025 20:59 GMT
… phase 2 ELM-2 trials (NCT03888105) provided context … Updated results from the trial were shared at the … steroids (33.3%), tocilizumab (Actemra; 16.7%), and both … treatment of relapsed/refractory follicular lymphoma. News release. Regeneron Pharmaceuticals …
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Expert: FDA-Approved Linvoseltamab Delivers Deep Responses, Offering New Hope For Older Patients With MM
24 Jul 2025 21:06 GMT
… , MBBS, professor of medicine—hematology and oncology at Mount … antibody approved for the treatment of relapsed or refractory … In the trial, investigators could use tocilizumab (Actemra; Genentech) or … grades. Now that the drug is commercially available, people …
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Developing a Bridge to Optimize Cellular Therapy Use in Multiple Myeloma
04 Aug 2025 20:59 GMT
… now, and some clinical trials that we believe will … starting to use drugs like tocilizumab [Actemra] as a cytokine … potential impact for administering the treatment outpatient and [among] … shots and administering other medications that help their cytopenia. …
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FDA Eases Access to CAR-T Therapies
10 Jul 2025 19:04 GMT
… drugs, such as tocilizumab (Actemra), and corticosteroids. To mitigate this risk, the FDA … burden on patients seeking transformative treatments for deadly blood cancers,” Stephen … of the Alliance for Regenerative Medicine, told BioSpace. Information about CAR …
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Blockbuster Novartis Drug Fails Key Test Hoped to Expand Its Use to Rare Blood Vessel Disorder
06 Jul 2025 16:41 GMT
… disorders.
Roche’s Actemra already enables steroid tapering … arm. On secondary trial goals measuring cumulative … diseases,” Novartis Chief Medical Officer Shreeram Aradhye said … treatment of plaque psoriasis. Since then, the drug has landed additional FDA …
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Novartis’ Cosentyx shows no benefit in Phase III GCA trial
04 Jul 2025 16:06 GMT
… countries.
Novartis’ chief medical officer Dr Shreeram Aradhye, … treatment. Patients may also be treated with Actemra (tocilizumab … and Drug Administration (FDA) in January 2015 for the treatment … industry insights.
Clinical Trials Arena Excellence Awards - …
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Novartis drug flunks phase 3 test in giant cell arteritis
03 Jul 2025 12:53 GMT
… warrant additional testing of the drug in GCA.
While disappointing for … are already approved by the FDA for GCA.
In 2017, … ;s anti-IL-6 antibody Actemra (tocilizumab) was approved for adults … treatment for the disorder based on results of the SELECT-GCA trial …
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FDA Approves Linvoseltamab-Gcpt for Treatment of Relapsed or Refractory Multiple Myeloma
02 Jul 2025 19:31 GMT
… escalation portion of the trial investigated linvoseltamab’s safety … Actemra; Genentech) to treat CRS.1,4,5
The FDA … Standard of Care Treatments. National Library of Medicine. ClinicalTrials.gov … Multiple Myeloma. Applied Clinical Trials. Published June 17, 2024 …
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FDA Expands Access to Approved CAR T-Cell Therapies by Eliminating REMS
01 Jul 2025 02:55 GMT
… Janssen Biotech, Inc)
Tisagenlecleucel (Kymriah; Novartis Pharmaceuticals Corporation)
… access to tocilizumab (Actemra; Genentech). Patients are … treatments while continuing to prioritize safety.”
References
FDA … ;/www.fda.gov/vaccines-blood-biologics…
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FDA Removes REMS for Currently Approved BCMA-, CD19-Directed CAR T Cell Immunotherapies
30 Jun 2025 21:34 GMT
… delivery of potentially curative treatments to patients and … to ensure drug safety in certain medications with serious … site access to tocilizumab (Actemra; Genentech), which is … treatments while continuing to prioritize safety.”1
REFERENCES
1. FDA. FDA …