• Regulatory NewsRegulatory News

    NICE, Roche Reach Deal on Breast Cancer Drug

    Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday. Currently, the UK pays for Kadcyla through its Cancer Drugs Fund, which requires patients to apply for funding to get access. The announcement comes just six months after NICE issued its second draft guidance rejecti...
  • Regulatory NewsRegulatory News

    WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall

    The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries. The two cancer treatments—Roche's Rituxan (rituximab) and Herceptin (trastuzumab)—make the top ten list for highest grossing drugs worldwide and cost in the tens of thousands of dollars pe...
  • UK: NICE Says No to Two Breast Cancer Drugs

    In final guidance published 27 June, the UK's National Institute for Health and Clinical Excellence (NICE) does not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors as first line treatment options for metastatic breast cancer. The guidance notes it is unclear how much either drug can improve overall survival compared to existing treatments and as a result they do not represent value for money for the NHS. Th...
  • UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance

    The National Institute for Health and Clinical Excellence (NICE) will not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors for a particular type and stage of breast cancer, the agency said in a final draft guidance issued 26 April. The proposal notes that it is unclear how much either drug can improve overall survival compared to existing treatments and that the drugs do not appear t...