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<![CDATA[All Respond to BCMA/CD19 CAR T-Cell Therapy in NDMM Trials]]>
19 Dec 2025 18:59 GMT
… Hospital of the Naval Medical University in China.
How … therapy with lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVd). On … end point in both trials. Secondary end points … respectively.
The most common treatment-emergent adverse effects in …
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<![CDATA[Johnson & Johnson’s Tecvayli Combo Wins FDA National Priority Voucher]]>
17 Dec 2025 02:48 GMT
… voucher. When a treatment demonstrates outstanding trial results, we have … & Johnson Innovative Medicine, said in a press … 2025.
5. Doctors for America. FDA Commissioner’s National Priority … (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in …
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<![CDATA[Teclistamab/Daratumumab Earns FDA Priority Voucher for R/R Myeloma]]>
17 Dec 2025 01:06 GMT
… England Journal of Medicine, supported the FDA’s decision … the series of MajesTEC trials have been launched to … voucher. When a treatment demonstrates outstanding trial results, we have … pomalidomide (Pomalyst; DPd) or bortezomib (Velcade; DVd) in patients with …
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<![CDATA[FDA Awards National Priority Voucher to Teclistamab Plus Daratumumab in Relapsed/Refractory Multiple Myeloma]]>
16 Dec 2025 22:04 GMT
… (Sirturo; Janssen Biotech) for drug-resistant tuberculosis in … autotemcel (Casgevy; Vertex Pharmaceuticals) for sickle cell disease … (DPd) or daratumumab, bortezomib (Velcad; Takeda Oncology), … . When a treatment demonstrates outstanding trial results, we …
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<![CDATA[FDA Grants National Priority Voucher to Teclistamab/Daratumumab in RRMM]]>
15 Dec 2025 22:42 GMT
… large unmet medical need, promoting domestic drug development … and dexamethasone (DPd) or bortezomib (Velcade) and dexamethasone (DVd) … ;refractory multiple myeloma.
FDA Commissioner Marty Makary, … . When a treatment demonstrates outstanding trial results, we …
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<![CDATA[FDA Grants National Priority Voucher to Tecvayli Combination in Relapsed or Refractory Multiple Myeloma]]>
15 Dec 2025 21:47 GMT
… voucher. When a treatment demonstrates outstanding trial results, we have … & Johnson Innovative Medicine, said in a press … cancer
Sirturo (bedaquiline) for drug-resistant tuberculosis in … (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in …
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<![CDATA[Bispecifics in New Combos, New Uses, and Earlier Lines of Treatment in Myeloma]]>
15 Dec 2025 19:45 GMT
… , associate professor of medicine at the University of … Therapeutics, Division of Cancer Medicine, The University of … the best treatment up front.”
The FDA approved linvoseltamab … bortezomib (Velcade) (DVd); this was called the DPd or DVd group. The trial …
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FDA ‘proactively’ awards J&J a national priority review voucher for multiple myeloma drug combo
16 Dec 2025 00:48 GMT
… an application. Normally, FDA drug reviews take up to … statement. “When a treatment demonstrates outstanding trial results, we have … Pomalyst or Takeda’s Velcade, among multiple myeloma … refractory patients, but other doctors and regulators will worry …
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<![CDATA[FDA Awards National Priority Voucher to Teclistamab Plus Daratumumab in R/R Myeloma]]>
15 Dec 2025 21:33 GMT
… unmet medical need; promoting domestic drug development … (DPd) or daratumumab plus bortezomib (Velcade) and dexamethasone (DVd; … safety, any-grade treatment-emergent adverse effects ( … given, per trial protocol.
References
FDA proactively awards national …
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<![CDATA[Experts Spotlight ASH 2025 Data Poised to Change Treatment Paradigms in AML, MZL, and Myeloma ]]>
12 Dec 2025 16:02 GMT
… departure from long-standing treatment norms, according to experts … of Pharmacy and Biotechnology and Department of … TRANSCEND FL trial (NCT042458839) support the recent FDA approval … pomalidomide [Pomalyst; DPd] or bortezomib [Velcade; DVd]. Those [data are …
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