Spectrum submits belinostat NDA

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) submitted an NDA to FDA seeking accelerated approval for belinostat to treat relapsed or refractory peripheral T cell lymphoma (PTCL). The company requested Priority Review. The application is based on data from the open-label Phase II BELIEF (PXD101-CLN-19) trial, in which once-daily IV belinostat met the primary endpoint of an objective response rate (ORR) of 20% or greater in 129 patients with relapsed or refractory PTCL (see BioCentury Extra, March 5).

Partner Topotarget A/S (CSE:TOPO) is eligible to receive a $10 million milestone and 1 million Spectrum shares on FDA acceptance of the NDA for belinostat. The company is also eligible for a $24 million milestone upon FDA approval. Spectrum has rights from Topotarget to co-develop and commercialize the small molecule histone deacetylase (HDAC) inhibitor in North America and India. ...