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F. Hoffmann-La Roche Ltd: European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy


F. Hoffmann-La Roche Ltd: European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
leukaemia
azacitidine
significantly improved overall survival in patients ineligible for intensive chemotherapy, a patient population who typically have a five-year overall survival rate of less than 10%
1
Venclyxto
-based combinations to provide clinically meaningful benefits in difficult to treat blood cancers
Basel, 25 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. ....

United States , Nathalie Meetz , Jon Kaspar Bayard , Levi Garraway , Karl Mahler , Mabthera Rituxan , Sabine Borngr , Gerard Tobin , Bruno Eschli , Venclexta Venclyxto , Birgit Masjost , Loren Kalm , Lisa Tuomi , Patrick Barth , Karsten Kleine , National Cancer Institute , Leukemia Lymphoma Society , European Commission , Drug Administration , Cancer Treatment Centers Of America , Head Of Global Product Development , Roche Group , Roche Group Media Relations , Chief Medical Officer , Global Product , Breakthrough Therapy Designations ,

Investegate |F. Hoffmann-La Roche Ltd Announcements | F. Hoffmann-La Roche Ltd: European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy


azacitidine
significantly improved overall survival in patients ineligible for intensive chemotherapy, a patient population who typically have a five-year overall survival rate of less than 10%
1
Venclyxto
-based combinations to provide clinically meaningful benefits in difficult to treat blood cancers
Basel, 25 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
“This Venclyxto approval is a critical step in providing new therapeutic options for patients in the EU newly diagnosed with AML who cannot tolerate the side effects of, or are ineligible for, intensive chemotherapy,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Develop ....

United States , Nathalie Meetz , Levi Garraway , Venclexta Venclyxto , Patrick Barth , Karsten Kleine , National Cancer Institute , Leukemia Lymphoma Society , European Commission , Drug Administration , Cancer Treatment Centers Of America , Head Of Global Product Development , Health Professional Version , Roche Group , Pharmaceuticals Industry , Roche Group Media Relations , Chief Medical Officer , Global Product , Breakthrough Therapy Designations , World Health Organization Model Lists , Essential Medicines , Dow Jones Sustainability Indices , Chugai Pharmaceutical , Adult Acute Myeloid Leukemia Treatment , Health Professional , Treatment Centers ,

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


(0)
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 ....

United States , Nathalie Meetz , Levi Garraway , Daniel Grotzky , Roche Tecentriq , Patrick Barth , Karsten Kleine , World Health Organization , Cancer Treatment Centers Of America , Drug Administration , Head Of Global Product Development , Advisory Committee , Approval Program , Oncologic Drugs Advisory Committee , Roche Group , Pharmaceuticals Industry , Roche Group Media Relations , Chief Medical Officer , Global Product , Programmed Death , World Health Organization Model Lists , Essential Medicines , Dow Jones Sustainability Indices , Chugai Pharmaceutical , Health Organization , Breast Cancer ,