HUTCHMED (China) Ltd

OTC Pink - Current Information:HMDCFUnited States

Apr 26, 2024

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• European Medicines Agency Committee Backs Approval of Takeda's Fruquintinib to Treat Colorectal Cancer, from 10:06AM ET on Friday Apr 26, 2024 by MT Newswires

  10:06AM ET on Friday Apr 26, 2024 by MT Newswires
  Companies Mentioned: TAK, HCM
  10:06 AM EDT, 04/26/2024 (MT Newswires) -- Takeda Pharmaceutical (TAK) has been notified that the European Medicines Agency's Committee for Medicinal Products for Human Use is recommending the approval of fruquintinib to treat adults with previously...

• HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda, from 8:30AM ET on Friday Apr 26, 2024 by GlobeNewswire

  8:30AM ET on Friday Apr 26, 2024 by GlobeNewswire
  Companies Mentioned: HMDCF

• HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda, from 8:30AM ET on Friday Apr 26, 2024 by Dow Jones

  8:30AM ET on Friday Apr 26, 2024 by Dow Jones
  Companies Mentioned: TAK, HCM
  Monitor liver function tests (ALT, AST, and bilirubin) before initiation and periodically throughout treatment with FRUZAQLA. Temporarily hold and then reduce or permanently discontinue FRUZAQLA depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests. -- Proteinuria. FRUZAQLA can cause proteinuria. In 911 patients with mCRC treated with FRUZAQLA, 36% experienced proteinuria and 2.5% of patients experienced Grade >=3 events. Monitor for proteinuria before initiation and periodically throughout treatment with FRUZAQLA. For proteinuria >=2g/24 hours, withhold FRUZAQLA until improvement to <=Grade 1 proteinuria and resume FRUZAQLA at a reduced dose. Discontinue FRUZAQLA in patients who develop nephrotic syndrome. -- Palmar-Plantar Erythrodysesthesia (PPE) occurred in 35% of 911 patients treated with FRUZAQLA, including 8% with Grade 3 events. Based on severity of PPE, withhold FRUZAQLA and then resume at the same or reduced dose. -- Posterior Reversible Encephalopathy Syndrome (PRES), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in one of 911 patients treated with FRUZAQLA. Perform an evaluation for PRES in any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue FRUZAQLA in patients who develop PRES. -- Impaired Wound Healing. In 911 patients with mCRC treated with FRUZAQLA, 1 patient experienced a Grade 2 event of wound dehiscence. Do not administer FRUZAQLA for at least 2 weeks prior to major surgery. Do not administer FRUZAQLA for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of FRUZAQLA after resolution of wound healing complications has not been established. -- Arterial Thromboembolic Events. In 911 patients with mCRC treated with FRUZAQLA, 0.8% of patients experienced an arterial thromboembolic event. Initiation of FRUZAQLA in patients with a recent history of thromboembolic events should be carefully considered. In patients who develop arterial thromboembolism, discontinue FRUZAQLA. -- Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF). FRUZAQLA 1 mg capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. FRUZAQLA 1 mg contains FD&C Yellow No. 6 (sunset yellow FCF), which may cause allergic reactions. -- Embryo-Fetal Toxicity. Based on findings in animal studies and its mechanism of action, FRUZAQLA can cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of childbearing potential and males with female partners of childbearing potential to use effective contraception during treatment with FRUZAQLA and for 2 weeks after the last dose.