Investor Update

Basel, 14 October 2016

Roche announces CHMP recommendation for EU approval of Venclyxto for people with hard-to-treat chronic lymphocytic leukaemia

  • First in class BCL2-specific oral inhibitor represents a new way of treating blood cancers

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto™ (venetoclax) for the treatment of people with chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor. Venclyxto is also recommended for the treatment of people with CLL without 17p deletion or TP53 mutation who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor. Based on this positive CHMP recommendation, a final decision regarding the conditional marketing authorisation of Venclyxto is expected from the European Commission in the coming months. Venclyxto is being co-developed by AbbVie and Roche.

"We are pleased that this positive CHMP opinion brings us closer to providing a much needed new treatment option to people in Europe with this difficult-to-treat disease," said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. "We look forward to continuing the development of this promising medicine in other blood cancers with our partner AbbVie."

Venclyxto is marketed as Venclexta® in the United States. Venclexta received accelerated approval from the US Food and Drug Administration (FDA) in April of this year for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. Venclexta/Venclyxto is the first approved medicine designed to trigger a natural process that helps cells self-destruct, providing a new way to help people who received previous treatment for their CLL or who have a high-risk form of CLL.

About Chronic Lymphocytic Leukaemia (CLL)

CLL is the most common type of leukaemia in the Western world. CLL mainly affects men and the median age at diagnosis is about 70 years. Worldwide, the incidence of all leukaemias is estimated to be over 350,000 and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells.

In certain cases of CLL, a part of chromosome 17 is lost and along with it an important gene that controls apoptosis (programmed cell death) called p53. The 17p deletion is found in 3 to 10 percent of previously untreated cases and up to 30 to 50 percent of relapsed or refractory cases.

About Venclexta/Venclyxto

Venclexta/Venclyxto is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). Overexpression of the BCL-2 protein in chronic lymphocytic leukaemia (CLL) has been associated with resistance to certain therapies. It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct. Venclexta/Venclyxto is being co-developed by AbbVie and Roche. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being evaluated in Phase III clinical trials for the treatment of relapsed, refractory and previously untreated CLL, along with studies in several other cancers. Venclexta/Venclyxto is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

About Roche in haematology

For more than 20 years, Roche has been developing medicines that redefine treatment in haematology. Today, we are investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), and Venclexta®/Venclyxto™ (venetoclax) in collaboration with AbbVie, Roche’s pipeline of investigational haematology medicines includes Tecentriq® (atezolizumab), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). Roche’s dedication to developing novel molecules in haematology expands beyond oncology, with the development of the investigational haemophilia A treatment emicizumab (ACE910).

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

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. 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.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine 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. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 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

All trademarks used or mentioned in this release are protected by law.