| Roche Says Avastin Study Misses Endpoint
Roche on Tuesday said a late-stage study of its cancer drug Avastin in combination with gemcitabine chemotherapy and Tarceva for pancreatic cancer did not meet the primary endpoint for survival. The phase III trial comparing gemcitabine chemotherapy and Tarceva with or without Avastin as first-line treatment for advanced pancreatic cancer showed some evidence of clinical activity on secondary endpoints but the trial did not meet the primary endpoint of overall survival, Roche said in a statement. Data from the AVITA trial are now being further analyzed to determine the extent of benefit of adding Avastin to the Tarceva/gemcitabine combination therapy, Roche said. Avastin is made by U.S. biotech firm Genentech .
Tarceva(R) (erlotinib) Earns Approval for Lung Cancer Patients in ...
BASEL, Switzerland & MELVILLE, N.Y.--(BUSINESS WIRE)--Roche and OSI Pharmaceuticals, Inc. (Nasdaq: OSIP - News) announced today that Tarceva® (erlotinib) has been approved in Japan for the treatment of patients with nonresectable, recurrent and advanced non-small cell lung cancer (NSCLC) which is aggravated following chemotherapy. The Japanese Ministry of Health approval means that lung cancer patients in Japan will now have an important new treatment, which has been demonstrated to increase overall survival and offer an improvement in quality of life. NSCLC is suffered by over one million people worldwide. It is the most common form of lung cancer and is more deadly than colon, breast, and prostate cancers combined.1 In 2005, the number of newly diagnosed patients with NSCLC in Japan reached 85,000.2 .
FDA Approves Administration of LEXIVA(R) with Lower Dose of 'Boosting ...
RESEARCH TRIANGLE PARK, N.C., Oct. 12 /PRNewswire-FirstCall/ -- GlaxoSmithKline's (NYSE: GSK) HIV protease inhibitor LEXIVA(R) (fosamprenavir calcium) may now be administered with 100mg of ritonavir, an agent that increases, or boosts, the level of protease inhibitors in the bloodstream. The U.S. Food and Drug Administration approved once-daily LEXIVA 1400 mg with 100mg of ritonavir in adult patients who had not previously taken a protease inhibitor (PI). The approval was based on pharmacokinetic data demonstrating comparable blood plasma levels in healthy volunteers when LEXIVA was administered with the lower 100mg dose of ritonavir and the previously approved 200mg dose of ritonavir. This information has been added to the LEXIVA product label. LEXIVA is indicated in combination with other antiretrovirals for the treatment of HIV infections.
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