Clinical Scorecard: FDA Grants Two Breakthrough Therapy Designations to Temab-A

At a Glance

Key Highlights

• The FDA granted Temab-A two Breakthrough Therapy Designations, one for use with bevacizumab in previously treated metastatic colorectal cancer and one for monotherapy in a biomarker-defined NSCLC population.
• The designations were based primarily on findings from the ongoing phase 1 M21-404 trial (NCT05029882).
• In a colorectal cancer dose-expansion analysis, confirmed objective response was 27% with Temab-A 2.4 mg/kg plus bevacizumab and 0% among evaluable patients receiving trifluridine/tipiracil plus bevacizumab.
• Grade 3 or higher treatment-emergent adverse events occurred in 67% of patients receiving the 2.4-mg/kg Temab-A combination and 65% receiving standard-of-care therapy.
• Breakthrough Therapy Designation is intended to expedite development and review; it is not FDA approval. Temab-A remains investigational.

Guideline-Based Recommendations

Diagnosis

• For the NSCLC designation, the population is defined by EGFR wild-type status, nonsquamous histology, and c-Met protein expression assessed centrally by immunohistochemistry in the trial.

Management

• The colorectal cancer designation covers Temab-A plus bevacizumab after prior fluoropyrimidine, irinotecan, oxaliplatin, and anti-VEGF therapy, and anti-EGFR therapy when indicated.
• The NSCLC designation covers Temab-A monotherapy after platinum-based chemotherapy and an anti–PD-(L)1 antibody.
• Temab-A is investigational and is not approved by regulatory authorities.

Monitoring & Follow-up

• In the colorectal cancer analysis, common adverse events with Temab-A 2.4 mg/kg plus bevacizumab included anemia (63%), nausea (60%), neutropenia (53%), fatigue (43%), and vomiting (40%).
• In the NSCLC dose-expansion cohort, grade 3 or higher treatment-emergent adverse events occurred in 63%; hematologic and gastrointestinal events were the most common overall.

Risks

• Grade 3 or higher treatment-emergent adverse events occurred in 67% with Temab-A 2.4 mg/kg plus bevacizumab versus 65% with standard-of-care therapy in the colorectal cancer analysis.
• Treatment-related adverse events led to discontinuation in 3% of patients receiving the Temab-A combination and 10% receiving standard-of-care therapy.

Patient & Prescribing Data

The colorectal cancer dose-expansion analysis included 83 patients; 30 received Temab-A 2.4 mg/kg plus bevacizumab and 20 evaluable patients received trifluridine/tipiracil plus bevacizumab. Patients were not selected by c-Met expression. The NSCLC dose-expansion data included 48 patients with EGFR wild-type, nonsquamous disease after prior platinum chemotherapy, immune checkpoint inhibition, and/or targeted therapy; c-Met protein expression was assessed centrally by immunohistochemistry.

Clinical Best Practices

• Interpret the Breakthrough Therapy Designations as development and review designations, not as evidence of FDA approval.
• Distinguish the colorectal cancer combination population from the biomarker-defined NSCLC monotherapy population when describing the designations.
• Note that the colorectal cancer analysis did not select patients by c-Met expression.

Related Resources & Content

• AbbVie. AbbVie’s Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC. October 7, 2026.