AbbVie’s investigational cancer drug telisotuzumab adizutecan, or Temab-A (ABBV-400), has received two Breakthrough Therapy Designations from the US FDA.

 

Thus, marking a significant regulatory boost for the global pharma powerhouse's next-generation antibody-drug conjugate program.

 

The FDA granted one designation for Temab-A in combination with bevacizumab for adults with refractory, metastatic colorectal cancer (CRC) who have already received multiple standard treatments, including fluoropyrimidine, irinotecan, oxaliplatin and anti-VEGF therapy, as well as anti-EGFR therapy where indicated.

 

The second designation covers Temab-A as a standalone treatment for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer (NSCLC) who have previously received platinum-based chemotherapy and anti-PD-(L)1 therapy.

 

Both designations were primarily supported by findings from AbbVie’s first-in-human Phase 1 study, M21-404.

 

"These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors," said Eleni Lagkadinou, vice president, oncology early development, AbbVie. 

 

"As one of the most advanced assets in our next-generation ADC portfolio, Temab-A has demonstrated potential across multiple tumor types, both as a monotherapy and in combinations. We believe these designations further support our strategy of advancing biomarker-driven therapies and underscore our commitment to developing transformative medicines for patients with difficult-to-treat cancers."

 

The two designations are the first Breakthrough Therapy Designations for Temab-A and bring AbbVie’s total number of such designations for its antibody-drug conjugate portfolio to four.

 

The drug combines a humanized bivalent IgG1 monoclonal antibody targeting c-Met with a topoisomerase 1 inhibitor payload. AbbVie says its adizutecan platform is designed to deliver the payload directly to tumor cells while limiting systemic exposure.

 

The company is testing Temab-A across a broad range of advanced solid tumors, including colorectal cancer, NSCLC, head and neck squamous cell carcinoma, gastroesophageal adenocarcinoma, pancreatic ductal adenocarcinoma and ovarian cancer.