For many women, a confirmation of pregnancy tends to evoke numerous emotions: excitement, shock, nervousness, joy, gratitude, and sometimes, even surprise. It is a moment dreamed, prayed, and planned for—but not for all.
To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
Experts in pharmacology and lung cancer urged physicians to prescribe the Amgen agent Lumakras (sotorasib) at the lowest tested dose—240 mg—instead of the four times higher dose of 960 mg recommended by the sponsor.
Imatinib—the pathbreaking cancer drug that gave Philadelphia chromosome-positive chronic myeloid leukemia patients near-normal life expectancies—now stands poised to save even more lives.
A novel study led by Friends of Cancer Research is providing evidence that tumor response rates can be assessed across real-world data sets, bringing regulators one step closer to potentially building a framework for pre-market evaluation of cancer drugs and post-market tracking of drug performance based on real-world endpoints.
If you’ve been following the saga of drug shortages in this publication, you know how America’s cancer institutions are scrambling to obtain platinum-based drugs for their patients.
In 1996, Carolyn Bertozzi and her lab at UC Berkeley were working to develop a way to image cell-surface glycans: sugar-based macromolecules that coat the surface of cells.
A mainstay of cancer treatment, doxorubicin is used as a standalone agent or in combination therapies, on-label and off, in at least 14 cancer types, including breast cancer, non-small cell lung cancer, and Wilms tumor.
The initial foray into genomic sequencing two decades ago has led to the discovery of key driver mutations and spurred drug development, thereby transforming the management of imminently lethal diseases.
Circulating tumor DNA has the potential to not only change the way medical oncologists assess and treat cancer patients, but also how cancer drugs are reviewed, oncology experts at FDA and pharmaceutical companies said in response to research findings published July 11 by a collaboration led by Friends of Cancer Research.
