Basel, Switzerland (Investor Update) – Roche (SIX: RO, ROG; OTCQX: RHHBY): today announced that fol­low­ing close consultation and agree­ment on study modifications with the U.S. Food and Drug Admin­istra­tion (FDA), the partial clin­i­cal holds placed on the Phase Ib and Phase Ib/II studies eval­u­ating TECENTRIQ in com­bi­na­tion with an immuno­modu­la­tory medicine (IMiD) in re­lapsed/refractory multiple myeloma and re­lapsed/refractory follicular lym­phoma have been lifted. The studies will con­tinue in accordance with the protocol amendments agreed upon by the FDA.

The studies had been placed on partial clin­i­cal hold as part of an FDA evaluation of all ongoing blood cancer trials, investigating PD-1/PD-L1 inhibitors in com­bi­na­tion with an IMiD to determine if there was a class-wide (PD-1/PD-L1 inhibitor) concern in multiple myeloma/blood cancers, or a specific concern with certain com­bi­na­tions with IMiDs. The FDA evaluation was prompted by interim data from clin­i­cal trials eval­u­ating pem­bro­lizu­mab in com­bi­na­tion with either lena­lido­mide or poma­lido­mide in multiple myeloma.

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. 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. Roche has been recognised as the Group Leader in sustainability within the Pharma­ceu­ticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people world­wide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 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.

Source: Roche.