Weekly Digest - December 2025

Weekly Digest - December 2025

02 December 2025: MHRA approves Tisotumab vedotin for the treatment of cervical cancer

  • The MHRA has approved Tisotumab vedotin (Tivdak) for adults with recurrent or metastatic cervical cancer whose disease has progressed after earlier lines of therapy, marking an important addition to the limited treatment options available for this population
  • The authorization was granted to Genmab through the International Recognition Procedure, and the MHRA noted that full product information will soon be available on its website, with the agency also encouraging patients and healthcare professionals to report any side effects through the Yellow Card scheme
  • Reinforcing its focus on patient protection, the MHRA highlighted that while Tivdak introduces a much-needed therapeutic option, the medicine will remain under ongoing post-approval safety monitoring to ensure real-world safety and effectiveness
  • Among the commonly observed side effects are eye-related disorders, such as conjunctivitis and keratitis, as well as peripheral neuropathy symptoms, including numbness, tingling, and burning sensations

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