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Xalkori Newsletter
  • FDA clears Nuvation's first product Ibtrozi, for lung cancer 12 Jun 2025 12:58 GMT

    … the FDA approved its ROS1 inhibitor Ibtrozi as a treatment for … "major milestone" in treatment, adding that Ibtrozi (taletrectinib) … drugs in the class, like Pfizer's first-to-market Xalkori … drug has been approved on the back of two phase 3 trials …

  • FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche 12 Jun 2025 13:56 GMT

    … and Drug Administration has approved a new oral medication for … 52% and 62% in those trials. Responses lasted as long … disappointed. Like many other biotechnology firms, it’s seen … drugs available for ROS1-positive lung cancers, among them Pfizer’s Xalkori …

  • David Hung's Nuvation Bio wins FDA approval for Ibtrozi to challenge Pfizer, BMS and Roche in lung cancer field 12 Jun 2025 02:05 GMT

    … will go up against existing medicines from Pfizer, Bristol Myers … tyrosine kinase inhibitor (TKI) Xalkori gradually falls out of favor … and 85% in the two trials, respectively. The numbers … Hung argued that doctors should still use the drug right upfront in …

  • US FDA approves Nuvation Bio’s rare lung cancer drug 11 Jun 2025 21:26 GMT

    … drug, taletrectinib, was based on results from two mid-stage trials … in which the drug demonstrated high response … , the company added. The drug, which is a ROS1 inhibitor … Squibb’s Augtyro, Pfizer’s Xalkori and Roche’s Rozlytrek. ( …

  • FDA Approves Taletrectinib in ROS1+ NSCLC 11 Jun 2025 17:43 GMT

    … received prior treatment with crizotinib (Xalkori). The TRUST-II trial enrolled patients … TRUST-I and TRUST-II trials, including those who were … in December 2024.4 FDA approves taletrectinib for ROS1 … U.S. Food and Drug Administration accepts for priority …

  • FDA Approves Taletrectinib for ROS1+ Advanced NSCLC 11 Jun 2025 23:27 GMT

    … TRUST-II (NCT04919811) trials.1 Treatment-naive patients experienced an … had progressed on crizotinib (Xalkori), which was the … in China during the trial. TRUST-II was … ;www.fda.gov/drugs/;resources-information-approved-drugs/fda-approves- …

  • Trump to sign executive order to reduce cost of prescription drugs and pharmaceuticals up to 80% 12 May 2025 02:18 GMT

    … wrote. 'The Pharmaceutical/Drug Companies would say, … Xeljanz, a treatment for autoimmune diseases including … Xalkori.  Drugmakers hiked up the prices of more than 770 drugs in 2024 alone — including medications … seen by a doctor. With insurance, copays …

  • Biotech Stocks Facing FDA Decision In June 2025 30 May 2025 13:05 GMT

    … following biotech companies are awaiting potential FDA approvals in … down 1.98%. KalVista Pharmaceuticals Inc. (KALV) Come … , doctors, and other healthcare workers who administer the vaccine. … lead drug candidate, Taletrectinib, proposed for the treatment of …

  • FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma 14 Apr 2025 23:38 GMT

    … trial," said Darrin Beaupre, MD, PhD, chief medical … its combination with crizotinib (Xalkori) in metastatic uveal … IDEAYA Biosciences receives US FDA breakthrough therapy designation … drug designation for darovasertib, a PKC inhibitor, for the treatment …

  • Taletrectinib Data Published as FDA Weighs Approval for ROS1+ NSCLC 08 Apr 2025 23:42 GMT

    … mg once daily. Common treatment-emergent adverse events (TEAEs)— … Medical Oncology Congress.3 Under the Prescription Drug User Fee Act, the FDA … population had prior crizotinib (Xalkori) and 8.8% had … 2 pivotal phase II trials of taletrectinib in patients …

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