AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan, known as Temab-A, in colorectal cancer and non-small cell lung cancer.

The first designation covers Temab-A in combination with bevacizumab for adults with refractory, metastatic colorectal cancer who have previously received fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody, and if indicated, anti-EGFR monoclonal antibody therapy. The second designation is for Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who have previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy.

Both designations were based primarily on results from the first-in-human study M21-404. Temab-A is an investigational antibody-drug conjugate that targets the c-Met protein and uses a topoisomerase 1 inhibitor payload. The drug has not been approved by any global regulatory authority.

The FDA's Breakthrough Therapy Designation program is designed to expedite development and review of investigational medicines that show clinical evidence of potential substantial improvement over existing therapies on one or more clinically significant endpoints.

According to AbbVie, these are the first such designations for Temab-A, bringing the total number of Breakthrough Therapy Designations across AbbVie's antibody-drug conjugate portfolio to four. Temab-A is also being evaluated in head and neck squamous cell carcinoma, gastroesophageal adenocarcinoma, pancreatic ductal adenocarcinoma, and ovarian cancer.