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On Wednesday, the FDA approved Merus N.V.’s (NASDAQ:MRUS) Bizengri (zenocutuzumab-zbco) as the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell ...
They promise to provide alternatives to platinum-based drugs for anticancer therapy. [1] [2] No ruthenium anti-cancer drug has been commercialized. Since 1979, when Cisplatin entered clinical trials, there has been continuing interest in alternative metal-based drugs. [3] The leading ruthenium-based candidates are BOLD-100 and TLD-1433.
The U.S. Food and Drug Administration (FDA) approved trastuzumab emtansine in February 2013, and granted the application for Kadcyla to Genentech. [18] The FDA granted the application for trastuzumab emtansine priority review and breakthrough therapy designations. [24] In 2013, trastuzumab emtansine was approved in the UK, [4] and the EU. [6]
In 2016, the FDA approved atezolizumab for urothelial carcinoma and non-small cell lung cancer. Avelumab (Bavencio) is a fully human IgG1 antibody developed by Merck Serono and Pfizer. Avelumab is FDA approved for the treatment of metastatic merkel-cell carcinoma. It failed phase III clinical trials for gastric cancer. [33]
The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Johnson & Johnson's chemotherapy-free combination treatment for a type of non-small cell lung cancer, setting up a challenge ...
In 2001 Pfizer/Wyeth's drug Gemtuzumab ozogamicin (trade name: Mylotarg) was approved based on a study with a surrogate endpoint, through the accelerated approval process. In June 2010, after evidence accumulated showing no evidence of benefit and significant toxicity, the U.S. Food and Drug Administration (FDA) forced the company to withdraw ...
Tevimbra is an anti-PD-1 monoclonal antibody, a similar class of treatments as Merck's blockbuster drug Keytruda, which helps the body's immune system detect and attack tumors.