December 21, 2017 Acad, Gov/Utilities

FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer

Basel, 21 December 2017 FDA approves Roche’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer Accelerated approval of Perjeta for neoadjuvant use also converted to full approval Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) has approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab)... Read more

December 21, 2017 Uncategorized

European Commission approves Roche’s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer

ALEX (NCT02075840/B028984) is a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in treatment-naïve people with ALK-positive NSCLC whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. People were randomised (1:1) to receive either... Read more

December 12, 2017 Bio/Pharma/CRO PR/Corporate

Roche announces phase III data showing Venclexta/Venclyxto plus MabThera/Rituxan reduced the risk of disease progression or death by 83% compared to a standard of care regimen in previously treated chronic lymphocytic leukaemia

Basel, 12 December 2017 Roche announces phase III data showing Venclexta/Venclyxto plus MabThera/Rituxan reduced the risk of disease progression or death by 83% compared to a standard of care regimen in previously treated chronic lymphocytic leukaemia This chemotherapy-free combination showed improvements across multiple efficacy measures compared to bendamustine plus MabThera/Rituxan in the pivotal MURANO trial... Read more

December 12, 2017 Bio/Pharma/CRO PR/Corporate

Roche announces phase III data showing Venclexta/Venclyxto plus MabThera/Rituxan reduced the risk of disease progression or death by 83% compared to a standard of care regimen in previously treated chronic lymphocytic leukaemia

Basel, 12 December 2017 Roche announces phase III data showing Venclexta/Venclyxto plus MabThera/Rituxan reduced the risk of disease progression or death by 83% compared to a standard of care regimen in previously treated chronic lymphocytic leukaemia This chemotherapy-free combination showed improvements across multiple efficacy measures compared to bendamustine plus MabThera/Rituxan in the pivotal MURANO trial... Read more

December 11, 2017 Bio/Pharma/CRO PR/Corporate

Phase III IMmotion151 study showed Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab) reduced the risk of disease worsening or death for the initial treatment of certain people with advanced kidney cancer

Basel, 11 December 2017 Phase III IMmotion151 study showed Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab) reduced the risk of disease worsening or death for the initial treatment of certain people with advanced kidney cancer Tecentriq and Avastin showed improvement in investigator-assessed progression-free survival (PFS) compared with sunitinib for people whose disease expressed PD-L1 Data will... Read more

December 11, 2017 Bio/Pharma/CRO PR/Corporate

Phase III IMmotion151 study showed Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab) reduced the risk of disease worsening or death for the initial treatment of certain people with advanced kidney cancer

Basel, 11 December 2017 Phase III IMmotion151 study showed Roche’s Tecentriq (atezolizumab) and Avastin (bevacizumab) reduced the risk of disease worsening or death for the initial treatment of certain people with advanced kidney cancer Tecentriq and Avastin showed improvement in investigator-assessed progression-free survival (PFS) compared with sunitinib for people whose disease expressed PD-L1 Data will... Read more

December 10, 2017 Bio/Pharma/CRO PR/Corporate

Phase II data showed Roche’s investigational polatuzumab vedotin plus bendamustine and MabThera/Rituxan (BR) increased complete response rates compared to BR alone in previously treated aggressive lymphoma

Basel, 10 December 2017 Phase II data showed Roche’s investigational polatuzumab vedotin plus bendamustine and MabThera/Rituxan (BR) increased complete response rates compared to BR alone in previously treated aggressive lymphoma Polatuzumab vedotin combination demonstrated improvements across multiple efficacy measures compared to BR alone in relapsed or refractory diffuse large B-cell lymphoma These data led to... Read more

December 9, 2017 Uncategorized

Roche’s Hemlibra continued to substantially reduce bleeds in people with haemophilia A with inhibitors

Basel, 09 December 2017 Roche’s Hemlibra continued to substantially reduce bleeds in people with haemophilia A with inhibitors Newly approved Hemlibra demonstrated superior efficacy compared to prior treatment with bypassing agents as prophylaxis or on-demand Nearly 95% of children who received Hemlibra experienced zero treated bleeds Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that... Read more

December 7, 2017 Bio/Pharma/CRO

Roche’s Hemlibra every four weeks controlled bleeds in phase III study in haemophilia A

Basel, 07 December 2017 Roche’s Hemlibra every four weeks controlled bleeds in phase III study in haemophilia A Less frequent administration of Hemlibra demonstrated clinically meaningful bleed control Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive interim results from the phase III HAVEN 4 study evaluating Hemlibra® (emicizumab) prophylaxis dosed once every four weeks... Read more

December 7, 2017 Bio/Pharma/CRO PR/Corporate

Phase III IMpower150 study showed Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy reduced the risk of disease worsening or death by 38 percent for people with a type of advanced lung cancer

Basel, 07 December 2017 Phase III IMpower150 study showed Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy reduced the risk of disease worsening or death by 38 percent for people with a type of advanced lung cancer First Phase III combination trial of a cancer immunotherapy to show improvement in progression-free survival as an initial treatment... Read more