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Nexavar Newsletter
  • The Targeted Pulse: FDA Approvals in HCC and CRC, Promise for SCLC, and More 20 Apr 2025 12:52 GMT

    … (Lenvima) or sorafenib (Nexavar; 20.6 months). The … FDA also approved the nivolumab plus ipilimumab for the first-line treatment … DeLLphi-304 (NCT03319940) trial demonstrated that tarlatamab-dlle … systems. Several clinical trials are investigating the INTRABEAM …

  • BMS gets another FDA okay for Opdivo/Yervoy combo 14 Apr 2025 12:25 GMT

    … open-label CheckMate-9DW trial. In the trial, Opdivo/Yervoy- … for HCC again after the drug was pulled from the market … a second-line treatment in people previously treated with Nexavar in the … which were cleared by the FDA in 2020 and 2022, respectively …

  • FDA Approves Nivolumab/Ipilimumab in First-Line Hepatocellular Cancer 11 Apr 2025 22:01 GMT

    … phase 3 CheckMate 9DW trial (NCT04039607). This combination … with other available treatment options. The FDA has approved nivolumab … lenvatinib (Lenvima) or sorafenib (Nexavar; HR, 0.79; … SOR) as first-line treatment for unresectable hepatocellular carcinoma …

  • FDA Approves Opdivo Plus Yervoy for Advanced HCC 11 Apr 2025 20:59 GMT

    The Food and Drug Administration (FDA) has approved the … in the CHECKMATE-9DW trial of 668 adults with … choice of Lenvima (lenvatinib) or Nexavar (sorafenib) monotherapy. The median … FDA approval that was granted to Opdivo plus Yerboy for the treatment …

  • FDA OKs Nivolumab/Ipilimumab in Unresectable/Metastatic HCC 11 Apr 2025 19:53 GMT

    … trial (NCT04039607) assessing nivolumab/ipilimumab vs lenvatinib (Lenvima) or sorafenib (Nexavar … hepatocellular carcinoma. News release. FDA. April 11, 2025. Accessed … and Drug Administration sBLA acceptance for first-line treatment of unresectable …

  • FDA Approves Nivolumab With Ipilimumab for First-Line Treatment of Adult Patients With HCC 11 Apr 2025 18:40 GMT

    … —either sorafenib (Nexavar; Bayer HealthCare Pharmaceuticals Inc.) or … 1,5 About the Trial Trial Name: A Study … www.fda.gov/drugs/;resources-information-approved-drugs/fda-approves … as first-line treatment for unresectable hepatocellular carcinoma ( …

  • Dr He on the FDA Approval of Nivolumab Plus Ipilimumab for Unresectable/Metastatic HCC 11 Apr 2025 22:15 GMT

    … , PhD, a gastrointestinal medical oncologist at the MedStar … CheckMate 9DW trial (NCT04039607), which supported the FDA approval of … a significant advancement in treatment outcomes compared with … (Lenvima)/sorafenib (Nexavar) comparator arm, the median …

  • FDA Approves Nivolumab/Ipilimumab for Metastatic or Unresectable HCC 11 Apr 2025 17:40 GMT

    … the CHECKMATE-9DW (NCT04039607) trial, which had a primary endpoint … sorafenib (Nexavar). The investigated dosage is recommended by the FDA. Efficacy … US Food and Drug Administration sBLA acceptance for first-line treatment of unresectable hepatocellular …

  • FDA Approves Nivolumab Plus Ipilimumab for Unresectable or Metastatic Hepatocellular Carcinoma 11 Apr 2025 16:31 GMT

    … 3 CheckMate 9DW trial (NCT04039607), which … s choice of sorafenib (Nexavar) or lenvatinib (Lenvima … as first-line treatment for unresectable hepatocellular carcinoma ( … #47;www.fda.gov/drugs/;resources-information-approved-drugs/fda-grants-accelerated …

  • Q2 2025: 7 FDA Decisions to Watch in the Realm of Oncology 05 Apr 2025 03:55 GMT

    … Squibb announced the FDA accepted its supplemental … survival compared to sorafenib (Nexavar) or lenvatinib (Lenvima). … clinical trials, including the phase 3 ENVISION trial (NCT05243550 … -Drug-Administration-sBLA-Acceptance-for-First-Line-Treatment-of …

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