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On October 17, the US FDA issued three guidelines on cancer therapeutics: "Acute myeloid leukemia (AML): developing drugs and biological products for treatment" final guidelines, "Research and development of tissue-independent drugs in tumors" draft guidelines, and "Immune-mediated adverse effects characterization, collection, and reporting in cancer immunotherapy clinical trials"
draft guidelines.
The three guides detail the FDA's current thinking
on the development of certain types of new cancer drugs.
Final guidelines for acute myeloid cell leukemia
Final guidelines for acute myeloid cell leukemia The final AML guidelines, originally published in draft two years ago, outline the FDA's thinking on AML drug development programs and clinical trial designs to support such products, including indications
for individual therapeutic phases.
The FDA states that "new drug classes are being developed
as alternatives to AML standard cytotoxic drugs.
" The following factors significantly complicate such new drug clinical development programs: expanded therapeutic intent, expanded intended populations, and the development of a broad class of
new drugs as alternatives to cytotoxic drugs.
”
These issues are considered in the guidance and include FDA perspectives
on topics such as efficacy endpoints, exploratory and confirmatory trial considerations, and AML regulatory filings.
FDA said the finalization guidelines have been updated
based on feedback received.
Includes several editorial changes clarifying bone marrow sampling and peripheral blood tests to establish a time frame for complete response, inclusion of label-negative patients in targeted therapy studies, and recommended procedural features
for safety discontinuation rules.
Immune-mediated adverse effects characterization, collection, and reporting in cancer immunotherapy clinical trials
Immune-mediated adverse effects characterization, collection, and reporting in cancer immunotherapy clinical trials The guidelines are intended to help sponsors develop cancer immunotherapy drugs
that modulate the endogenous immune system and may disrupt immune tolerance to normal organs and tissues.
FDA provides advice
on topics such as the type of data it wishes to collect and evaluate when evaluating potential adverse events.
The guidelines also focus on the type of data
that should be included in a drug application.
Development of tissue-independent drugs in tumors
Development of tissue-independent drugs in tumors In this guideline, the FDA makes recommendations
to sponsors on tissue-independent cancer drugs that target molecular alterations for multiple cancer types.
According to the FDA, "A tissue-independent oncology agent can be used to treat multiple types of cancers (e.
g.
, colorectal, thyroid, and breast cancers) with targeted molecular alterations (e.
g.
, identical targeted molecular alterations or targeted molecular alterations that affect a single pathway)
.
" ”
The guidelines discuss the need
in tissue-independent drug development to generalize the effects of treatment to other cancer types with the same targeted molecular alterations based on data observed in certain cancer types when no (or limited) subjects with other cancers are enrolled in clinical trials.
The FDA says this approach could speed up the development of
new treatments for patients with rare cancers when trials in larger populations may not be feasible.
The FDA requires sponsors to consider factors such as biology, subject population, clinical pharmacology, and clinical safety and efficacy
when deciding whether an organization-independent oncology drug development program is appropriate.
The guidelines also describe other issues to consider, such as non-clinical assessment, participant selection, study design, statistical considerations, endpoints, pediatrics, diagnostic considerations and labelling, and post-approval data and information
.
