Daiichi Sankyo and AstraZeneca have received priority review status from the US Food and Drug Administration (FDA) for their supplemental Biologics License Application (sBLA) concerning Enhertu in combination with pertuzumab. This expedited review process is a significant milestone, indicating the FDA’s recognition of the potential benefits this combination therapy may offer in treating patients with specific cancer indications.
The priority review designation typically shortens the review timeline to six months, compared to the standard ten months. This accelerated pathway not only reflects the FDA’s commitment to advancing innovative therapies but also underscores the urgency in addressing unmet medical needs within oncology. As the competitive landscape for cancer treatments intensifies, the swift approval process could position Enhertu as a key player in the market, potentially impacting treatment protocols and patient outcomes.
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