Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Alecensa for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer, as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor. “With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “At Genentech, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread. This approval brings us one step closer to achieving that mission.”
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on RHHBY:
- Roche announces data from its Phase III OCARINA II study of OCREVUS
- Genentech reports data from OCARINA II study of Ocrevus
- Roche’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS
- Roche price target raised to CHF 260 from CHF 250 at Morgan Stanley
- Fresenius SE launches biosimilar of Roche’s Actemra