FDA share new trial guidelines to further cancer therapy development
pharmafile | March 2, 2022 | News story | Research and Development |
The FDA has issued three recommendations to industry for clinical trials, to support US President Joe Biden’s relaunch of the 2016 ‘Cancer Moonshot’ initiative, which was announced last month. The new guidelines are designed to facilitate continued advancement in cancer prevention, detection, research, and patient care.
“With today’s actions the FDA is recommending important principles that involve addressing inequities, targeting the right treatments to the right patients, speeding progress against the most deadly and rare cancers, and learning from the experience of all patients,” said Richard Pazdur, M.D., Director for the FDA’s Oncology Center for Excellence. “All of these are tenets of Cancer Moonshot’s mission.”
The FDA guidance includes when to interact with the FDA on planning and conduct of multiple expansion cohort studies; safeguards to protect patients enrolled in these expansion cohort studies; characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial; and information to include in investigational new drug applications submissions to support the design of individual expansion cohorts.
“Inclusion of Older Adults in Cancer Clinical Trials,” provides recommendations for including older adult patients, namely those aged 65 years and older, in the clinical trials of drugs for the treatment of cancer. “It is vital to have older adult patients in clinical trials because differences may exist between younger and older patients in drug response and toxicity,” the agency shared.
Another guidance for industry, “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics,” gives recommendations on designing and conducting trials with multiple expansion cohorts, that allow for the simultaneous addition of patients into different cohorts, to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs.
Under the renewed Cancer Moonshot, the Biden’s government aims to reduce the mortality rate of cancer by as much as 50% over the next 25 years, and to “improve the experience of people and their families living with and surviving cancer.”
Ana Ovey
