Scemblix (asciminib) was granted accelerated approval by FDA for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments. Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were...
