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FDA grants Priority Review to Roche's polatuzumab vedotin in previously treated aggressive lymphoma

Nachrichtenquelle: GlobeNewswire
19.02.2019, 07:00  |  1258   |   |   

F. Hoffmann-La Roche Ltd / FDA grants Priority Review to Roche's polatuzumab vedotin in previously treated aggressive lymphoma . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

  • Diffuse large B-cell lymphoma is an aggressive type of blood cancer that typically becomes harder to treat each time it returns
  • Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease

  • Basel, 19 February 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by 19 August 2019.

    "Polatuzumab vedotin, a potential first-in-class antibody drug conjugate, in combination with bendamustine and Rituxan, improved clinical outcomes including survival in some people with relapsed or refractory diffuse large B-cell lymphoma compared to bendamustine and Rituxan alone," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "We are working with the FDA to bring this important new option to patients with this aggressive disease as quickly as possible."

    The BLA is based on results of the GO29365 study, which showed that polatuzumab vedotin plus BR improved median overall survival compared to BR alone (12.4 vs. 4.7 months, HR=0.42; 95% CI 0.24-0.75; exploratory endpoint), in people with R/R DLBCL not eligible for a haematopoietic stem cell transplant. The study also showed that 40% of people treated with polatuzumab vedotin plus BR achieved a complete response (CR), while only 18% of people treated with BR alone achieved a CR (primary endpoint, as measured by positron emission tomography; CR rates assessed by independent review committee). A CR means no cancer could be detected at that time.

    Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Polatuzumab vedotin was also granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with R/R DLBCL in 2017. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate substantial improvement over existing therapies.

    About the GO29365 study

    GO29365 is a global, phase Ib/II randomised study evaluating the safety, tolerability and activity of polatuzumab vedotin in combination with bendamustine and Rituxan (rituximab) or Gazyva (obinutuzumab) in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). The phase II stage randomised 80 patients with heavily pre-treated R/R DLBCL to receive either bendamustine plus Rituxan (BR), or BR in combination with polatuzumab vedotin. Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the polatuzumab vedotin arm and range of 1-5 prior therapies in the BR alone arm). The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography (PET) and assessed by an independent review committee (IRC). Secondary endpoints included objective response (OR; CR and partial response, PR) by investigator assessment and best objective response at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response (DOR), progression-free survival (PFS), event-free survival (EFS) and overall survival (OS).

    • 40% of people treated with polatuzumab vedotin plus BR achieved a CR while only 18% of people treated with BR alone achieved a CR (primary endpoint, as measured by PET; CR rates assessed by IRC). A CR means no cancer could be detected at that time.
    • Polatuzumab vedotin in combination with BR showed a median OS of over one year compared to the BR arm (12.4 vs. 4.7 months, HR=0.42; 95% CI 0.24-0.75), in people with R/R DLBCL not eligible for a hematopoietic stem cell transplant. OS was an exploratory endpoint.
    • Polatuzumab vedotin plus BR increased median PFS and led to a 66% reduction in risk of disease worsening or death compared to BR alone (median PFS: 7.6 months vs. 2.0 months; HR=0.34; 95% CI 0.20-0.57).
    • Patients treated with polatuzumab vedotin plus BR showed a longer time between first response to treatment and disease worsening than those receiving BR alone (investigator assessed median DOR: 10.3 months vs. 4.1 months; HR=0.44).
    • Updated safety results are similar to those previously described, with infections and cytopenias remaining the most common Grade 3-4 adverse events (AEs). Polatuzumab vedotin plus BR had higher rates of Grade 3-4 cytopenias compared to BR, however, infection and transfusion rates remained similar between arms.

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