Roche submits application to FDA for trastuzumab-DM1 in previously treated advanced HER2-positive breast cancer

T-DM1 is the first antibody-drug conjugate in Roche’s pipeline to be submitted to the FDA

09-Jul-2010 - Roche announced that the company submitted a Biologics Licence Application (BLA) to the U.S. Food and Drug Administration (FDA) for trastuzumab-DM1 (T-DM1) in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies. This ...

Second phase III study showed Avastin-containing regimen helped women with ovarian cancer live longer

06-Jul-2010 - Roche announced today that a second large, phase III, international study showed that the combination of Avastin (bevacizumab) and chemotherapy followed by the continued use of Avastin alone, increased the time women with previously untreated ovarian cancer lived without the disease worsening ...

Tarceva helps patients with genetically distinct form of lung cancer live longer

Phase II study points to importance of EGFR biomarker to identify patients who can gain exceptional survival benefits

10-Jun-2010 - New data show that first-line treatment with Tarceva (erlotinib) delivered exceptional survival benefits in patients with advanced lung adenocarcinoma (a form of non small cell lung cancer) with epidermal growth factor receptor (EGFR) activating mutations. Randomized Phase II trial of erlotinib ...

Genentech Announces Positive Results of Avastin Phase III Study in Women with Advanced Ovarian Cancer

First Phase III Study of an Anti-Angiogenic Therapy in Advanced Ovarian Cancer to Meet Primary Endpoint

02-Mar-2010 - Genentech, Inc. announced that a Phase III study showed the combination of Avastin® (bevacizumab) and chemotherapy followed by maintenance use of Avastin alone increased the time women with previously untreated advanced ovarian cancer lived without the disease worsening (progression-free survival ...

Herceptin now approved in the EU for patients with HER2-positive advanced stomach cancer

First targeted biological therapy to show survival benefit in stomach cancer

01-Feb-2010 - Roche announced that the European Commission has approved Herceptin (trastuzumab) in combination with chemotherapy for use in patients with HER2-positive metastatic stomach (gastric) cancer. The approval is based on the results from the international ToGA trial, which showed that treatment with ...

New Phase II study showed trastuzumab-DM1 shrank tumours in women with highly advanced HER2-positive breast cancer

T-DM1, an Investigational Antibody-Drug Conjugate, Showed Encouraging Results in Women Who Have Received Multiple Prior Medicines

14-Dec-2009 - Roche announced positive results from a Phase II study of trastuzumab-DM1 (T-DM1). As assessed by independent review, T-DM1 shrank the tumors (also known as objective response) in 33 percent of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous ...

Avastin filed for broader breast cancer label in Europe for use in combination with standard chemotherapies

30-Nov-2009 - Roche announced that they have filed to extend the current European label of Avastin (bevacizumab) in patients with metastatic breast cancer to allow its use in combination with a broader range of standard chemotherapies. Avastin is currently licensed in the EU as first-line treatment for ...

Roche: MabThera receives positive opinion in Europe for treating patients whose chronic lymphocytic leukaemia returns

Patients with relapsed or refractory disease can live ten months longer without their disease progressing

27-Jul-2009 - Roche announced that the European Union’s Committee on Human Medicinal Products (CHMP) has issued a positive recommendation for the use of MabThera (rituximab) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). Physicians will soon be able to prescribe MabThera, the ...

Roche: Xeloda in combination with oxaliplatin shown to be effective in early colon cancer

Phase III study meets primary endpoint of increasing the time patients live disease free compared with commonly used chemotherapy combination

21-Jul-2009 - Roche announced results from the international phase III study NO16968 (XELOXA), investigating oral Xeloda in combination with intravenous oxaliplatin (XELOX) immediately after surgery, which show that patients with colon cancer taking XELOX live disease free for longer compared to those taking ...

Avastin plus commonly used chemotherapies improved progression-free survival in advanced breast cancer

Data from RIBBON 1 study provides efficacy and safety information with different types of chemotherapy

19-May-2009 - Roche and Genentech provided an overview of results from the Phase III study (RIBBON 1) that showed Avastin® (bevacizumab) plus commonly used chemotherapies, including Xeloda® (capecitabine) and anthracycline-based therapies, increased the time women receiving first-line therapy for advanced ...