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(R) (atezolizumab) in combination with 
chemotherapy (Abraxane(R), 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 
that have not met their primary endpoint(s) and have yet to gain regular 
approvals. The advisory committee provides the FDA with independent 
opinions and recommendations from outside medical experts, though the 
recommendations are not binding. The FDA has not announced when it will 
make its final decision for Tecentriq in this indication. 
 
   "People with triple-negative breast cancer have few treatment options, 
which is why today's committee decision to recognise the importance of 
this Tecentriq combination is significant," said Levi Garraway, M.D., 
Ph.D., Roche's Chief Medical Officer and Head of Global Product 
Development. "We are grateful to the FDA and ODAC for the open dialogue 
and look forward to continued collaboration to improve the lives of 
people with breast cancer." 
 
   The FDA's Accelerated Approval Program allows for conditional approval 
of a medicine that fills an unmet medical need for a serious condition, 
with specific postmarketing requirements (PMRs) to confirm the clinical 
benefit and convert to regular approval. 
 
   Tecentriq was granted accelerated approval in March 2019 for the 
treatment of adults with PD-L1-positive, unresectable locally advanced 
or mTNBC based on the positive progression-free survival (PFS) results 
from the IMpassion130 study. Continued approval for this indication was 
contingent upon the results of IMpassion131, the PMR for the mTNBC 
indication. 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 cancer 
 
   Breast cancer is the most common cancer among women with more than 2 
million diagnosed worldwide each year(.1) TNBC represents 15% of all 
breast cancers and is more common in women under the age of 50, compared 
with other forms of breast cancer.(2-4) It is defined by the lack of 
expression and/or amplification of the targetable receptors for 
oestrogen, progesterone and HER2 amplification.(5) Patients with mTNBC 
generally experience rapid progression and shorter overall survival 
compared to other subtypes of breast cancer.(3) 
 
   About Roche in breast cancer 
 
   Roche has been advancing breast cancer research for more than 30 years 
with the goal of helping as many people with the disease as possible. 
Our medicines, along with companion diagnostic tests, have contributed 
to bringing breakthrough innovations in HER2-positive and triple 
negative breast cancers. As our understanding of breast cancer biology 
rapidly improves, we are working to identify new biomarkers and 
approaches to treatment for all forms of early and advanced breast 
cancer, including triple-negative and hormone receptor-positive. 
 
   Our targeted medicines Herceptin, Perjeta, Phesgo, Kadcyla and Tecentriq 
are continuing to transform the treatment of early and advanced 
HER2-positive and triple negative breast cancers and, through our 
clinical programmes, we hope to bring new treatment combinations to 
people with breast cancer, ultimately improving outcomes. 
 
   About 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. 
 
   Tecentriq is approved in the US, EU and countries around the world, 
either alone or in combination with targeted therapies and/or 
chemotherapies in various forms of NSCLC, SCLC, certain types of 
metastatic urothelial cancer, in PD-L1-positive metastatic 
triple-negative breast cancer and for hepatocellular carcinoma. In the 
US, Tecentriq is also approved in combination with Cotellic(R) 
(cobimetinib) and Zelboraf(R) (vemurafenib) for the treatment of people 
with BRAF V600 mutation-positive advanced melanoma. 
 
   About Roche in cancer immunotherapy 
 
   Roche's rigorous pursuit of groundbreaking science has contributed to 
major therapeutic and diagnostic advances in oncology over the last 50 
years, and today, realising the full potential of cancer immunotherapy 
is a major area of focus. With over 20 molecules in development, Roche 
is investigating the potential benefits of immunotherapy alone, and in 
combination with chemotherapy, targeted therapies or other 
immunotherapies with the goal of providing each person with a treatment 
tailored to harness their own unique immune system to attack their 
cancer. Our scientific expertise, coupled with innovative pipeline and 
extensive partnerships, gives us the confidence to continue pursuing the 
vision of finding a cure for cancer by ensuring the right treatment for 
the right patient at the right time. 
 
   In addition to Roche's approved PD-L1 checkpoint inhibitor, Tecentriq(R) 
(atezolizumab), Roche's broad cancer immunotherapy pipeline includes 
other checkpoint inhibitors, such as tiragolumab, a novel cancer 
immunotherapy designed to bind to TIGIT, individualised neoantigen 
therapies and T-cell bispecific antibodies. 
 
   To learn more about Roche's scientific-led approach to cancer 
immunotherapy, please follow this link: 
 
   http://www.roche.com/research_and_development/what_we_are_working_on/oncology/cancer-immunotherapy.htm 
 
 
   About Roche 
 
   Roche is a global pioneer in pharmaceuticals and diagnostics focused on 
advancing science to improve people's lives. The combined strengths of 
pharmaceuticals and diagnostics under one roof have made Roche the 
leader in personalised healthcare -- a strategy that aims to fit the 
right treatment to each patient in the best way possible. 
 
   Roche is the world's largest biotech company, with truly differentiated 
medicines in oncology, immunology, infectious diseases, ophthalmology 
and diseases of the central nervous system. Roche is also the world 
leader in in vitro diagnostics and tissue-based cancer diagnostics, and 
a frontrunner in diabetes management. 
 
   Founded in 1896, Roche continues to search for better ways to prevent, 
diagnose and treat diseases and make a sustainable contribution to 
society. The company also aims to improve patient access to medical 
innovations by working with all relevant stakeholders. More than thirty 
medicines developed by Roche are included in the World Health 
Organization Model Lists of Essential Medicines, among them life-saving 
antibiotics, antimalarials and cancer medicines. Moreover, for the 
twelfth consecutive year, Roche has been recognised as one of the most 
sustainable companies in the Pharmaceuticals Industry by the Dow Jones 
Sustainability Indices (DJSI). 
 
   The Roche Group, headquartered in Basel, Switzerland, is active in over 
100 countries and in 2020 employed more than 100,000 people worldwide. 
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 
58.3 billion. Genentech, in the United States, is a wholly owned member 
of the Roche Group. Roche is the majority shareholder in Chugai 
Pharmaceutical, Japan. For more information, please visit www.roche.com. 
 
   All trademarks used or mentioned in this release are protected by law. 
 
   References 
 
   [1] World Health Organization: Globocan 2020 -- Breast Cancer Factsheet. 
[Internet; cited 15 April] Available from: 
https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf. 
 
 
   [2] Yao H et al. Triple-negative breast cancer: is there a treatment on 
the horizon? Oncotarget. 2017;8(1):1913--1924. 
 
   [3] BreastCancer.org. What is Triple-Negative Breast Cancer? [Internet; 
cited 15 April] Available from: 
https://www.breastcancer.org/symptoms/diagnosis/trip_neg?what. 
 
   [4] Cancer Treatment Centers of America. Triple negative breast cancer 
risk factors. [Internet; cited 15 April] Available from:

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April 27, 2021 18:25 ET (22:25 GMT)