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FDA permits Curis to resume testing for experimental breast cancer drug
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Curis Inc. recently reported that the FDA has allowed the company to resume testing of its experimental cancer drug for advanced and refractory solid tumors or lymphomas, lifting a November order halting enrollment in a phase 1 trial.
The FDA ordered the halt following the death a patient with advanced breast cancer who suffered liver failure a month after discontinuing treatment with Curis’ drug, CUDC-427.
The drug is designed to neutralize major inhibitors of apoptosis or programmed cell death – a process that ensures defective, damaged or superfluous cells are eliminated.
Curis stated that it intended to continue testing the drug as a monotherapy and evaluate its use in combination with chemotherapy drug, capecitabine, in patients with advanced breast cancer.