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F Hoffmann-La Roche Ltd: European Commission approves Roche s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer

F. Hoffmann-La Roche Ltd: European Commission approves Roche s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer 1,2,3 administered under the skin in just minutes compared to hours with intravenous ( IV) infusion of Perjeta plus Herceptin 4,5,6 Approval is based on results from the pivotal phase III FeDeriCa trial, which showed that Phesgo delivered non-inferior 7 Basel, 23 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Phesgo , a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection for the treatment of early and metastatic HER2-positive breast cancer.

San antonioUnited statesNathalie meetzHalozyme enhanzeLevi garrawayDaniel grotzkyJon kaspar bayardKarl mahlerSabine borngrGerard tobinBruno eschliBirgit masjostLisa tuomiLoren kalmPatrick barthKarsten kleine

F Hoffmann-La Roche Ltd: Roche launches cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer in countries accepting the CE mark

(2) This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which may lead to cancer PIK3CA is the most commonly mutated gene in advanced or metastatic breast cancer, with nearly 40 percent of patients harbouring a mutation in this gene 1 The cobas PIK3CA Mutation Test is a PCR-based test that detects PIK3CA mutations in patients with metastatic breast cancer to help identify those most likely to benefit from approved therapy 2 Basel, 15 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas PIK3CA Mutation Test for patients with advanced or metastatic breast cancer. Previously only available as research use only (RUO), this in vitro diagnostic (IVD) test is now available in countries accepting the CE mark.

United statesNathalie meetzJon kaspar bayardDaniel grotzkyKarl mahlerSabine borngrGerard tobinBruno eschliBirgit masjostLoren kalmLisa tuomiThomas schineckerPatrick barthKarsten kleineRoche groupPharmaceuticals industry

F Hoffmann-La Roche Ltd: FDA approves Roche s OCREVUS (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

(2) Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional OCREVUS dosing regimen Shorter infusion time will further improve the twice-yearly treatment experience for OCREVUS, the only B-cell therapy for relapsing and primary progressive MS with a twice-yearly dosing schedule Basel, 14 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The approval was based on data from the randomised, double-blind ENSEMBLE PLUS study.

United statesNathalie meetzJon kaspar bayardLevi garrawayDaniel grotzkyKarl mahlerSabine borngrGerard tobinBruno eschliBirgit masjostLoren kalmLisa tuomiPatrick barthKarsten kleineDrug administrationHead of global product development

F Hoffmann-La Roche Ltd: Roche launches laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients

F Hoffmann-La Roche Ltd: Roche launches laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
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United statesNathalie meetzDaniel grotzkyJon kaspar bayardKarl mahlerSabine borngrGerard tobinBruno eschliBirgit masjostLisa tuomiActemra roactemraThomas schineckerLoren kalmPatrick barthKarsten kleineDrug administration

F Hoffmann-La Roche Ltd: Roche presents exploratory data from the Phase III IMvigor010 study in early bladder cancer at the ESMO Immuno-Oncology Virtual Congress 2020

F. Hoffmann-La Roche Ltd: Roche presents exploratory data from the Phase III IMvigor010 study in early bladder cancer at the ESMO Immuno-Oncology Virtual Congress 2020 25.8 DFS, HR (95% CI) (0.19-0.60) About bladder cancer and muscle-invasive urothelial cancer In 2018, there were over half a million new cases of bladder cancer diagnosed globally, with approximately 200,000 deaths from the disease. 4 Urothelial cancer is the most common type of bladder cancer, accounting for about 90-95% of all cases. 5 MIUC is a type of urothelial cancer that has spread into the muscle of the bladder, ureter or renal pelvis. 6 Approximately 25% of new cases of bladder cancer are diagnosed with muscle-invasive disease,

United statesNathalie meetzLevi garrawayDaniel grotzkyJon kaspar bayardKarl mahlerSabine borngrGerard tobinBruno eschliBirgit masjostLisa tuomiLoren kalmPatrick barthKarsten kleineAmerican society of clinical oncologyUrology care foundation