US regulators used a fast-track approval process for asciminib in the treatment of chronic myeloid leukemia (CML), despite its availability of existing medications. Asciminib is one of six tyrosine kinase inhibitors for CML and was granted accelerated approval for newly diagnosed patients. Concerns have been raised about the rapid approval process, with some questioning the need for new drugs when existing options are effective. Researchers and oncologists have expressed doubts about the use of surrogate endpoints and the speed of confirmatory research. The debate continues over the use of accelerated approval for drugs in settings where existing treatments are already highly effective.
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Accelerated Approval of New TKI Use in CML Sparks Questions
