Cardiff’s onvansertib Fast Track’d for certain type of colorectal cancer

The FDA designates Cardiff Oncology’s (CRDF +13.5%) onvansertib for Fast Track review for the second-line treatment of patients with KRAS mutation-positive metastatic colorectal cancer (mCRC).

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

A Phase 1b/2 clinical trial evaluating onvansertib, combined with Roche’s Avastin and the chemo regimen FOLFIRI, in KRAS-positive mCRC patients is in process.

Onvansertib inhibits an enzyme called serine/threonine polo-like-kinase 1 (PLK1) which is overexpressed in a range of blood cancers and solid tumors.

https://seekingalpha.com/news/3578279-cardiffs-onvansertib-fast-trackd-for-certain-type-of-colorectal-cancer