FDA grants Temab-A dual Breakthrough status

The designations cover refractory metastatic CRC and previously treated c-Met–expressing NSCLC.

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The FDA granted telisotuzumab adizutecan (Temab-A) Breakthrough Therapy Designations for previously treated metastatic colorectal cancer and biomarker-defined advanced nonsquamous NSCLC.
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The colorectal cancer designation covers Temab-A plus bevacizumab for refractory disease after specified chemotherapy and biologic treatments.
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In a phase 1 dose-expansion analysis, confirmed objective response rates were 27% with Temab-A 2.4 mg/kg plus bevacizumab, 15% with the 2.0-mg/kg combination, and 0% with trifluridine/tipiracil plus b
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The NSCLC designation covers Temab-A monotherapy for previously treated EGFR wild-type, c-Met protein–expressing, nonsquamous disease.
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Temab-A remains investigational and is not FDA-approved; Breakthrough Therapy Designation is intended to expedite development and review, not to confer approval.

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