FDA Requirements for Rare Oncology Drugs Often Drug-Drug Interactions Say Scholars

Nearly half of rare oncology drug approvals include postmarketing requirements (PMR) for drug-drug interactions (DDI), a particular concern for cancer patients who are frequently being treated for co-morbidities and palliative care.

A recent study showed that of the 39 FDA rare oncology therapeutics approvals from January 2019 to March 2023, 49 percent of agency PMRs were for DDIs, and 49 percent were for specific populations.

That’s according to a team of researchers from Kura Oncology, Novartis and Johnson & Johnson’s Janssen unit and Regeneron, among other industry stakeholders, who published their findings earlier this month in the Journal of Pharmacokinetics and Pharmacodynamics.

The scholars also stressed the different risks affecting DDIs.

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