Urgent changes to Australia’s drug regulatory system are needed to cope with genomic discoveries that are ‘fracturing’ diseases such as breast cancer into rarer and rarer subtypes, an expert says.
If patients with genetic subtypes of cancer were to access potentially life-saving drugs in future, regulators worldwide might need to start accepting a lesser standard of evidence of drug efficacy, according to Dr David Thomas of Melbourne’s Peter MacCallum Cancer Centre.
“The molecular testing of cancer types is fracturing up what appeared to be homogenous cancer subtypes into a range of rarer, less common subtypes and we are now treating the sub-types,” he told Oncology Update this week.
“There are all sorts of implications about how you effectively and rapidly conduct trials when...
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