Ambit Biosciences and Teva Pharmaceutical Industries have announced the FDA clearance of CEP-32496, a novel BRAF (V600E) kinase inhibitor.
The preclinical findings also demonstrate that CEP-32496 possesses potent and sustained anti-tumor activity in xenograft models of melanoma and colon carcinoma.
CEP-32496 possesses attractive pharmacokinetic properties upon oral administration, the company said.
Teva oncology and inflammation discovery research senior director Bruce Ruggeri said, "We look forward to exploring the full potential of this drug candidate to improve outcomes in patients with tumors possessing the BRAF(V600E) mutation."
In the preclinical studies, CEP-32496 demonstrated tumor stasis and regressions with favorable activity compared to other kinase inhibitors, including sorafenib and RAF-265, at doses that were well tolerated.
