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F. Hoffmann-La Roche Ltd: Roche's Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer


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Tecentriq
significantly improved overall survival in people with high PD-L1 expression, compared with chemotherapy in a Phase III study
Tecentriq
This approval marks
Tecentriq s
fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall in the EU
Basel, 5 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression , with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.
We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer, said Levi Garraway, M.D., Ph.D., Roche s Chief Medical Officer and Head of Global Product Development. Tecentriq monotherapy has been shown to improve overall survival in peop ....

United States , Nathalie Meetz , Jon Kaspar Bayard , Levi Garraway , Daniel Grotzky , Karl Mahler , Sabine Borngr , Gerard Tobin , Bruno Eschli , Birgit Masjost , Loren Kalm , Lisa Tuomi , Patrick Barth , Karsten Kleine , World Health Organization , European Commission , Pharmaceuticals Industry , Head Of Global Product Development , Roche Group Media Relations , American Cancer Society , Chief Medical Officer , Global Product , World Conference , Lung Cancer , Programmed Death , World Health Organization Model Lists ,

Investegate |F. Hoffmann-La Roche Ltd Announcements | F. Hoffmann-La Roche Ltd: US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche's Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer


F. Hoffmann-La Roche Ltd
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7 to 2 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumours express PD-L1, as determined by an FDA-approved test. Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials t ....

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Investegate |F. Hoffmann-La Roche Ltd Announcements | F. Hoffmann-La Roche Ltd: US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche's Tecentriq for previously untreated metastatic bladder cancer


F. Hoffmann-La Roche Ltd
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer
US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for previously untreated metastatic bladder cancer
Basel, 28 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq® (atezolizumab) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumours express high levels of PD-L1 (PD-L1–stained tumour-infiltrating immune cells covering ≥5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy ....

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F. Hoffmann-La Roche Ltd: US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche's Tecentriq for previously untreated metastatic bladder cancer


F. Hoffmann-La Roche Ltd: US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche s Tecentriq for previously untreated metastatic bladder cancer
Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person s immune system combats cancer more effectively. ....

United States , Nathalie Meetz , Jon Kaspar Bayard , Levi Garraway , Daniel Grotzky , Karl Mahler , Sabine Borngr , Gerard Tobin , Bruno Eschli , Birgit Masjost , Loren Kalm , Lisa Tuomi , Patrick Barth , Karsten Kleine , Approval Program , Oncologic Drugs Advisory Committee , World Health Organization , Drug Administration , Pharmaceuticals Industry , Head Of Global Product Development , Chief Medical Officer , Global Product , Programmed Death , World Health Organization Model Lists , Essential Medicines , Dow Jones Sustainability ,

F. Hoffmann-La Roche Ltd: CHMP recommends EU approval of Roche's ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD)


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If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU
ENSPRYNG is the only subcutaneous treatment option for NMOSD that can be administered at home every four weeks
Recommendation is based on results from the two pivotal Phase III
SAkuraStar
SAkuraSky
studies, in which ENSPRYNG demonstrated robust and sustained efficacy in reducing the risk of relapse and a
favourable
safety profile
NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system that can cause blindness, muscle weakness and paralysis ....

United States , Nathalie Meetz , Jon Kaspar Bayard , Levi Garraway , Daniel Grotzky , Karl Mahler , Sabine Borngr , Gerard Tobin , Bruno Eschli , Birgit Masjost , Loren Kalm , Lisa Tuomi , Patrick Barth , Karsten Kleine , European Medicines Agency , European Commission , Roche Group , Head Of Global Product Development , Committee For Medicinal Products Human Use , Roche Group Media Relations , Medicinal Products , Human Use , Chief Medical Officer , Global Product , ஒன்றுபட்டது மாநிலங்களில் , ஜான் காஸ்பர் வளைகுடா ,