“THERE is no treatment.” This is the conclusion of an Egyptian papyrus, written around 3000BC, that is the oldest known description of the scourge that is now called “cancer”. And so, more or less, it remained until the 20th century, for merely excising a tumour by surgery rarely eliminates it. Only when doctors worked out…
Owing to the high clinical failure rates, genetically variable tumor characteristics, and skyrocketing drug development costs, the era of traditional blockbuster oncology agents has come to an end. With the advent of personalized medicine, we have entered the “niche-buster” era, defined as effective products delivered to identifiable patient segments. The good news is that all…
History’s path is unchartable when it’s not yet past but present, when we are still standing in the middle of it. That’s what made Science’s selection of this year’s Breakthrough of the Year such a topic of internal debate, even anxiety. In celebrating cancer immunotherapy—harnessing the immune system to battle tumors—did we risk hyping an approach…
U.S. regulators on Friday approved Gilead Sciences Inc’s Sovaldi, also known as sofosbuvir, as a potential cure for chronic infection with the liver-destroying hepatitis C virus. The once-a-day pill is the first approved to treat certain types of hepatitis C infection without the need for interferon, an injected drug that can cause severe flu-like symptoms.…
The peri-approval period between completion of registration trials and FDA approval of a new cancer medicine presents a “window of opportunity” for conducting dose comparison studies, a multi-stakeholder panel said Nov. 7 at the 2013 Conference on Clinical Cancer Research. Conducting further dose exploration as part of an expanded access program before drug approval could…
WASHINGTON, DC — The advocacy group Friends of Cancer Research (FOCR) announced at a conference here the activation of an ambitious “master” clinical trial protocol for squamous cell lung cancer, an innovative, collaborative public/private partnership, which aims to start enrolling patients by next spring. The trial protocol is believed to be unique. The protocol consists…
Many people with serious or life-threatening illnesses for which there are no satisfactory treatments are understandably eager to gain access to new therapies and are willing to trade off greater certainty about a drug’s performance for speed of access. Because the typical clinical drug-development program takes about 7 years, during which a substantial body of…
The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics ($PCYC) and Johnson & Johnson ($JNJ). The agency cut months off the traditional timeline for the drug, marking another quick OK for a “breakthrough” drugs, following the approval of Roche’s ($RHHBY) Gazyva two weeks ago.…
The 72-year-old man had tried every approved drug option available to treat the advanced kidney cancer that had spread throughout his body. As a last resort, he signed up for the first clinical trial of nivolumab, an experimental drug from Medarex and Bristol-Myers Squibb (BMS) that inhibits a protein called programmed death-1 (PD-1), which has…
This morning at a meeting in Washington, D.C., researchers from the academia, the Food and Drug Administration, the National Cancer Institute, a leading patient advocacy group and several drug companies are describing a new clinical trial in lung cancer that could fundamentally change the way cancer drugs are studied and approved, speeding medicines that target specific…
