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news.The FDA has approved Chroma Therapeutics' investigational new drug application, clearing the company to progress its experimental cancer therapy to its second phase II trial.
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UK-based Chroma said that it will shortly start its second phase II trial, in non-small cell lung cancer (NSCLC). This follows the recent initiation of a phase II trial for this drug in acute myeloid leukaemia.
The approval was based on a phase I study for the drug which showed one partial responder and six patients with confirmed stable disease of at least three months duration, out of a total of 41 patients treated with a variety of doses of the drug, Chroma said. The drug was well-tolerated during the study and drug exposure was consistent with the proposed once-daily oral dosing.
Ian Nicholson, CEO of Chroma, said: “We are pleased to have met this major milestone with the approval of Chroma's first IND application and to be entering our second phase II clinical trial. We believe the phase I data demonstrates this new agent could be used for the treatment of a number of solid tumors, including NSCLC, a patient group which has substantial unmet medical need.”