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News
The FDA has granted breakthrough therapy designation to telisotuzumab adizutecan (Temab-A) plus bevacizumab for refractory metastatic colorectal cancer (mCRC) in patients who've exhausted multiple prior treatments. Phase 1 data showed the combo nearly doubled progression-free survival compared to the current standard of care. A global phase 3 trial is now underway to confirm these results.
The FDA has granted breakthrough therapy designation to telisotuzumab adizutecan (Temab-A), a c-Met–directed antibody-drug conjugate (ADC), in combination with bevacizumab for adults with refractory metastatic colorectal cancer (mCRC) who have already been treated with fluoropyrimidine, irinotecan, oxaliplatin, and anti-VEGF therapy. The designation was driven by early but compelling data from a phase 1 trial.
In that trial, patients receiving Temab-A at 2.4 mg/kg plus bevacizumab showed a median progression-free survival (PFS) of 6.8 months — compared to just 4.2 months with the current standard-of-care regimen (TAS-102 plus bevacizumab). Median overall survival in the Temab-A arm had not yet been reached, versus 9.6 months in the control arm — a notable early signal.
By the Numbers:
Why it matters: Refractory mCRC has very limited treatment options, making this designation a meaningful step forward. A phase 3 global trial (AndroMETa-CRC) is now comparing the combo head-to-head against standard care, with overall survival as a primary endpoint.
