The pivotal study for SAR302503 nailed the primary endpoint for the proportion of patients with a greater than 35% reduction in the volume of their spleens, which become enlarged as a result of abnormal blood cell production.
Researchers at the Frederick National Laboratory for Cancer Research have developed a way to enhance delivery of a cancer drug using nanoparticles, enabling more of the toxic therapy to reach the tumor without killing healthy cells.
Merck ($MRK) has a shot at a speedy development path for lambrolizumab. The FDA has pinned a "Breakthrough Therapy" tag on the experimental antibody drug for advanced melanoma, based on Phase Ib data that showed significant early signs of anti-tumor activity in some patients with aggressive cases of the deadly skin cancer.
Blogger Pieter Droppert reports details this morning on drug giant AbbVie's ($ABBV) suspension of multiple clinical trials for an experimental leukemia drug code-named ABT-199, writing that a "reliable" source tells him that the trials were halted after the death of a patient in a study. Now the company confirms there were two deaths, but that the delay in the program is only temporary.
The biotech field is covered with startup efforts with cancer drugs, but when Dr. Patrick Soon-Shiong announces one the business world stops and listens.
Pfizer and Novartis emerged as winners this week in a review of drug applications in the European Union, with delegates backing approval of the drug giants' new meds. With both drugs, the FDA beat its European counterpart to the punch with approvals last year.
MacroGenics has landed a licensing deal with the biopharma powerhouse Gilead Sciences that could be worth more than $1.1 billion if four pre-clinical programs go perfectly.
Cancer researchers have been rethinking the way new drugs are developed as investigations of new medicines focus more on molecular targets than on the organs where tumors originate. And this evolution in clinical development has crossed paths with the race to advance drugs that restore function of a protein to send cancer cells to their grave.
The company plans to advance the program, which has fast-track status in the U.S., to an FDA review next year.
Shares of Oncolytics Biotech jumped more than 60% this morning after the Canadian biotech revealed positive data on one endpoint from a Phase III study of its anticancer virus in patients with head and neck cancers.