To the Editor: Darrow et al. (March 27 issue)1 present an incomplete and misleading review of the Food and Drug Administration (FDA) programs that are available to expedite drug development, review, and approval. As the authors note, drug regulation involves balancing the potential benefits of access to a therapy against the potential risks associated with the…
A bold new way to test cancer drugs started Monday in hundreds of hospitals around the U.S. In a medical version of speed dating, doctors will sort through multiple experimental drugs and match patients to the one most likely to succeed based on each person’s unique tumor gene profile. It’s a first-of-a-kind experiment that brings…
A new way of evaluating tumors may soon help cancer patients identify the underlying genetic link to their disease – and the best possible treatment – all in a single test. Researchers are set to begin clinical trials using a more comprehensive testing method that looks for all of the known genes that may be…
Final guidance on expedited regulatory pathways suggests FDA is open to accelerated approval for some acute conditions; agency also provides examples outside of HIV/cancer arena where surrogate and intermediate clinical endpoints have supported approval. FDA’s final guidance on expedited programs for drugs and biologics takes a more welcoming approach to the use of accelerated approval…
The nation will mark two important cancer milestones this year: the 1964 Surgeon General’s Report on Smoking and Health and the founding of the American Society of Clinical Oncology (ASCO), which ushered in a medical specialty focusing specifically on cancer care. Fast forward 50 years and there is a lot to celebrate. Cancer deaths dropped…
Colorado, Missouri and Louisiana are poised to become the first states in the nation to give terminally ill patients the right to try experimental drugs without the blessing of the Food and Drug Administration, setting the stage for what could be a lengthy battle over who should decide whether a drug is too risky to try. Lawmakers…
FDA’s top drug official, responding to criticism about the high price of breakthrough drugs, said the agency is driving toward cures for diseases like cancer and hepatitis, but there will be a transition and possibly “a big down payment” required. Both FDA drug center Director Janet Woodcock and a research advocate played up the potential…
LONDON, April 17 (Reuters) – Scientists and drugmakers are pioneering a new kind of clinical trial that changes the way cancer drugs are studied, potentially cutting both the time and cost of bringing them to market. Instead of testing one drug at a time, a novel lung cancer study announced on Thursday will allow British…
Building on enthusiasm for the multi-sponsor, multi-drug clinical trial due to get underway in lung cancer soon, stakeholders in academia, industry, government and the patient community have begun discussions about a similar, biomarker-driven trial in colon cancer. The concept of a clinical trial “master protocol” is expanding into other disease areas even before the inaugural…
Draft guidance calls for a clear statement in the Indications and Usage section of labeling that reflects a drug’s clearance under accelerated approval on the basis of a particular surrogate or clinical endpoint. The document also includes provisions for reflecting the withdrawal of accelerated approval in labeling. FDA is proposing changes in the Indications and…
