Company Overview of Genentech, Inc.
Genentech, Inc., a biotechnology company, engages in the research, discovery, development, manufacture, and marketing of biotechnology products using human genetic information for patients with serious or life-threatening diseases in the United States. The company focuses on developing monoclonal antibodies, small molecules, and antibody drug conjugates for use in various therapeutic areas, such as cardiovascular, immunology, infectious diseases, metabolism, neuroscience, oncology, ophthalmic diseases, biomarker assay technologies, and therapeutic lead discovery technologies. It also offers Xolair (omalizumab) for the treatment of chronic idiopathic urticaria. Genentech, Inc. has a strategic...
1 DNA Way
South San Francisco, CA 94080-4990
Founded in 1976
Key Executives for Genentech, Inc.
Co-Founder and Member of Scientific Resource Board
Executive Vice President of Research & Early Development and Member of Executive Committee
Senior Vice President and General Counsel
Compensation as of Fiscal Year 2014.
Genentech, Inc. Key Developments
FDA Grants Genentech's Avastin Priority Review for Certain Types of Cervical Cancer
Jul 15 14
Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin(R) (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer. The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide "significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications." The sBLA for Avastin plus chemotherapy in persistent, recurrent or metastatic cervical cancer is based on data from the Phase III GOG-0240 trial with an FDA action date of October 24, 2014. GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored Phase III study which assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent or metastatic cervical cancer. Study data from 452 women showed: The study met its primary endpoint of improving overall survival (OS) with a statistically significant 29% reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 17.0 months vs. 13.3 months; Hazard Ratio (HR)=0.71, p=0.004). Women in the Avastin plus chemotherapy arm also lived longer without disease worsening (progression free survival, PFS) compared to those who received chemotherapy alone (median PFS: 8.2 months vs. 5.9 months; HR=0.67, p=0.002). Hypertension (high blood pressure) of Grade 2 or higher was significantly more common with Avastin-containing regimens (25% vs. 2%), but no patients discontinued Avastin because of hypertension. Gastrointestinal or genitourinary fistulas (abnormal passage from one part of the body to another) of Grade 3 or higher were significantly increased with the Avastin-containing regimens (6% vs. 0%), as were thromboembolic events (blood clots) of Grade 3 or higher (8% vs. 1%). There was no increase in treatment-related deaths in the Avastin plus chemotherapy arm as compared to the chemotherapy alone arm.
Genentech Announces the Phase III Cobrim Study Met Primary Endpoint
Jul 14 14
Genentech announced that the Phase III coBRIM study met its primary endpoint. The study demonstrated that the investigational MEK inhibitor cobimetinib, used in combination with Genentech's BRAF inhibitor Zelboraf, helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer without their disease worsening (progression-free survival; PFS) compared to Zelboraf alone. Data from this pivotal study will be presented at an upcoming medical meeting. Additionally, Genentech plans to submit these data to the FDA for potential approval. Cobimetinib is designed to selectively block the activity of MEK, one of a series of proteins inside cells that make up a signaling pathway that helps regulate cell division and survival.
Genentech, Inc. Presents at BIO International Convention, Jun-24-2014 11:00 AM
Jun 17 14
Genentech, Inc. Presents at BIO International Convention, Jun-24-2014 11:00 AM. Venue: San Diego Convention Center, San Diego, California, United States.
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