FDA Breakthrough granted for Roche’s Gazyva
The designation was based on the Phase II NOBILITY study.
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Tag: obinutuzumab
AZ’ Calquence hits endpoints in late-stage leukemia trial
The success marks the second Calquence pivotal trial in CLL to meet its primary endpoint early.
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AbbVie, Roche present positive Venclyxto results at ASCO
Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 protein.
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Trial results show promise for chemo-free future treatment
95% of those treated in the study were found to have a complete remission rate.
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Imbruvica/Gazyva combo improves PFS in CLL patients
A combination of AbbVie/Johnson & Johnson’s Imbruvica and Roche’s Gazyva has taken a step closer to becoming first chemotherapy-free CD20 combination for first-line treatment of chronic lymphocytic leukaemia (CLL), after showing promise in a late-stage clinical trial.
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Roche’s Gazyvaro gets NICE nod for high-risk lymphoma patients
Cost regulators for NHS treatments in England and Wales have now recommended funding for Roche’s Gazyvaro for some patients with untreated follicular lymphoma, after the submission of new data by the company.
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SMC bars four medicines from NHS
The Scottish Medicines Consortium has rejected NHS funding for four new therapies, including Bristol-Myers Squibb and Roche’s respective cancer medicines Opdivo and Gazyvaro.
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Roche bags new approvals for Hemlibra, Gazyva
US regulators have issued a green light for Roche’s haemophilia A therapy Hemlibra and also expanded the scope of Gazyva to include untreated advanced follicular lymphoma.
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NICE rejects first-line use of Roche’s Gazyvaro
The National Institute for Health and Care Excellence has turned down first-line use of Roche’s Gazyvaro in patients with untreated advanced follicular lymphoma on the NHS in England and Wales.
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NICE backs Roche’s Gazyvaro for follicular lymphoma
The National Institute for Health and Care Excellence has issued final draft guidance recommending that use of Roche’s Gazyvaro to treat follicular lymphoma be funded for NHS use via the Cancer Drug Fund.
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SMC welcomes Roche’s Gazyvaro but rejects Shire’s Onivyde
Patients with follicular lymphoma in Scotland have gained a new treatment option for the condition after the Scottish Medicines Consortium (SMC) published advice accepting Roche’s Gazyvaro for routine use by NHS Scotland. On the downside, funding for Shire’s Onivyde to treat pancreatic cancer was rejected.
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Roche’s Gazyva fails to hit target in lymphoma trial
Roche’s new blood cancer drug Gazyva has failed to show significant improvements versus veteran therapy MabThera/Rituxan in patients with previously untreated diffuse large B-cell lymphoma, marking a setback in plans to protect sales from biosimilar competition.
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- Lindus Health and Quotient Sciences announce strategic partnership to accelerate drug development
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