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Nov 6, 2026Regulatory decision

FDA grants accelerated approval to zongertinib for expanded lung cancer indication

The agency cleared the kinase inhibitor for adults with unresectable or metastatic non-squamous non-small cell lung cancer.

The FDA announced accelerated approval of zongertinib, described as a kinase inhibitor, for an expanded indication. FDA granted accelerated approval to zongertinib, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer.1

The FDA's posted notice does not include further detail beyond this indication statement.

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