FDA data requirements supporting novel drug approvals vary widely, depending on therapeutic area, with cancer drugs given greatest leniency, suggesting products may need a clinical trial “quality grade,” according to an analysis published in the Journal of the American Medical Association. Another study shows cancer treatments are most likely to get approved on the…
FDA Office of Hematology & Oncology Products Director Richard Pazdur, MD, sat down to discuss the state of cancer R&D, Breakthrough therapies, and how his staff pushes to complete those speedy three-month reviews during The RPM Report’s FDA/CMS Summit for Biopharmaceutical Executives in December. Here is a transcript of the conversation, edited for clarity. Q: Oncology…
When the I-SPY 2 trial launched in 2010, oncologists heralded it as the future of cancer research. Five pharmaceutical companies put aside their differences to participate in the landmark phase 2 breast cancer trial, which adaptively and efficiently randomized patients to one of seven experimental therapies. Now, even as I-SPY 2 propels its first two…
A few years ago, when Michel Sadelain spoke about adoptive cell transfer (ACT) therapy at cancer meetings, his colleagues were dubious about what seemed a drastic and unconventional approach: harvesting and genetically altering his patient’s immune cells to train them to attack her cancer. “I can’t tell you how many nearly empty rooms I’ve spoken…
“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…
