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# FDA Puts Marengo’s Invikafusp on Fast Track
- URL: https://www.fdaweb.com/fda-puts-marengos-invikafusp-on-fast-track/
- Published: 2025-01-09T12:00:00.000Z
- Updated: 2026-09-14T14:50:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158458

FDA has granted fast track designation for Marengo Therapeutics’ invikafusp alfa to treat unresectable, locally advanced, or metastatic colorectal cancers with high tumor mutational burden. A company [statement](https://www.prnewswire.com/news-releases/marengos-first-in-class-invikafusp-alfa-star0602-receives-us-fda-fast-track-designation-for-treatment-of-unresectable-locally-advanced-or-metastatic-colorectal-cancers-with-high-tumor-mutational-burden-tmb-h-302344827.html?ref=fdaweb.com) says the designation was informed by encouraging results from Marengo’s first-in-human clinical study of invikafusp alfa in heavily pretreated cancer patients. It says the data reinforced the drug’s anti-tumor activity and favorable safety profile. A Phase 2 trial of invikafusp alfa is ongoing, Marengo says.

The statement says invikafusp alfa is the first T cell activator generated from Marengo’s STAR multi-specific antibody-fusion platform.