Tesaro's (TSRO) Rolapitant drug for the prevention of chemotherapy-induced nausea and vomiting (CINV) has met the primary and secondary goals of a Phase III study of 532 cancer patients, achieving statistical significance compared with standard treatments.
The data adds to the positive results of two other late-stage trials, the results of which Tesaro announced in December.
Tesaro plans to apply for FDA approval of Rolapitant in mid-2014; the treatment would compete with Merck's Emend.
The company's shares are +18.7%, while those of Opko Health (OPK), which sold Tesaro rights to Rolapitant for as much as $121M in up-front and milestone payments, are +0.5%. (PR)