Takeda’s pevonedistat nabs accelerated review in U.S. for bone marrow cancer

The FDA has designated Takeda Pharmaceutical Company Limited’s (NYSE:TAK) pevonedistat a Breakthrough Therapy for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS), a type of bone marrow cancer with a poor prognosis.

Phase 3-stage pevonedistat is an NEDD8-activating enzyme (NAE) inhibitor. The company says its kills cancer cells by blocking the modification of certain proteins which disrupts cell cycle progression and survival.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

https://seekingalpha.com/news/3597567-takedas-pevonedistat-nabs-accelerated-review-in-u-s-for-bone-marrow-cancer