US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche ’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. As the clinically meaningful benefit demonstrated in the IMpassion130 study remains, Roche looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication.Roche remains committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. Tecentriq has already demonstrated its transformational role in areas of high medical need and is a first in class medicine approved for particularly difficult to treat cancers. Tecentriq ’s extensive development programme includes multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings.Tomorrow, on 28 April, the ODAC will discuss Tecentriq ’s accelerated approval for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy.About triple-negative breast cancerBreast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year.1 TNBC represents ~15% of all breast cance...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news

Related Links:

More News: Allergy & Immunology | Biology | Biotechnology | Bladder Cancer | Breast Cancer | Breast Carcinoma | Cancer | Cancer & Oncology | Carcinoma | Chemotherapy | Diabetes | Endocrinology | Food and Drug Administration (FDA) | Gastroenterology | Head and Neck Cancer | Hepatocellular Carcinoma | HER2 | Herceptin | Hormones | Immunotherapy | Infectious Diseases | International Medicine & Public Health | Internet | Japan Health | Learning | Liver Cancer | Melanoma | Men | Neoadjuvant Chemotherapy Therapy | Neoadjuvant Therapy | Non-Small Cell Lung Cancer | OBGYN | Opthalmology | Partnerships | Pharmaceuticals | Science | Skin | Skin Cancer | Small Cell Lung Cancer | Study | Switzerland Health | Universities & Medical Training | USA Health | WHO | Women