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     555  0 Kommentare Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia

    F. Hoffmann-La Roche Ltd / Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

    • Fixed 12-month treatment with Venclexta plus Gazyva significantly reduced risk of disease progression or death by 67% compared to a current standard-of-care
  • Approval for expanded use of Venclexta offers more adults with chronic lymphocytic leukaemia a new treatment option

  • Basel, 16 May 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

    "Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard-of-care," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "Today's approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukaemia."

    The approval is based on the results of the randomised phase III CLL14 study, which evaluated 12-month, fixed-duration treatment with Venclexta plus Gazyva compared to Gazyva plus chlorambucil. Results showed the combination of Venclexta plus Gazyva produced a durable and significant reduction in the risk of disease worsening or death (progression-free survival [PFS], as assessed by Independent Review Committee) by 67% compared to Gazyva plus chlorambucil, a current standard-of-care (HR=0.33; 95% CI 0.22-0.51; p<0.0001). Venclexta plus Gazyva showed deep and clinically meaningful responses characterised by a higher rate of minimal residual disease (MRD)-negativity in the bone marrow compared to Gazyva plus chlorambucil (MRD-negativity of 57% vs. 17%) and peripheral blood (MRD-negativity of 76% vs. 35%). MRD-negativity means no cancer can be detected using a specific and highly sensitive test, defined as less than one CLL cell in 10,000 white blood cells.

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    Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia F. Hoffmann-La Roche Ltd / Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia . Processed and transmitted by West Corporation. The issuer is solely responsible for the content …

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