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  • Capping Busy Week, FDA Approves Breast Cancer, Multiple Myeloma Drugs

    The US Food and Drug Administration (FDA) approved two new drug entities for treating, respectively, certain forms of breast cancer and multiple myeloma on Friday, 20 July. The approvals capped off a busy week for the agency, marking the fourth approval and second new molecular entity in the five-day period. Afinitor (everolimus) , manufactured by Novartis Pharmaceuticals, was approved for the treatment of postmenopausal women with advanced formone-receptor positive, HE...
  • UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance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Roche) with aromatase inhibitors for a particular type and stage of breast cancer, the agency said in a final draft guidance issued 26 April.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...
  • NICE Denies Avastin Indication for Breast Cancer

    The UK's National  Institute for Health and Clinical Excellence (NICE) announced in a draft guidance it will not approve Roche's breast cancer drug Avastin (bevacizumab) due to "too many uncertainties" about the drug's cost effectiveness, writes In Pharm . "The draft guidance, which is out for consultation, has not recommended Avastin as first line treatment for metastatic breast cancer in combination with chemotherapy drug capecitabine," wrote In Pharm . NICE's ...
  • Agency Releases Rationale Behind Withdrawal of Avastin's Breast Cancer Indication

    The US Food and Drug Administration (FDA) released on 27 February the text of their final decision on their withdrawal of Avastin's (bevacizumab) breast cancer indication . FDA Commissioner Margaret Hamburg's 69-page decision is meant to be an explanation of FDA's application of the law and relevant regulations in its decision to withdraw approval for Avastin's breast cancer indication. Avastin is still marketed for several other indications. The action followed a pu...