Australian health authorities have revealed at least one patient has died from taking part in a clinical trial of a controversial cancer drug.
The drug, Zydelig, works by blocking particular proteins inside cancer cells that encourage the cancer to grow.
After inquiries from the ABC, a spokesman for the TGA revealed “a death has been reported to the TGA for a patient suffering from chronic lymphocytic leukaemia (CLL) participating in a clinical trial involving Zydelig and another drug, ofatumumab”.
“Between 1 January 2014 and 18 November 2015, nine cases of adverse events have been reported in association with Zydelig,” a TGA spokesman said.
“A review of this data by the TGA has shown that two of these reports relate to early access patients, while the rest relate to clinical trials.”
The drug, once hailed as a “revolutionary treatment” that “melts away” cancer cells is now being investigated by Australian health authorities after some patients died while taking the medication in clinical trials overseas.
Drug maker Gilead Sciences Inc was carrying out six clinical trials to find out whether Zydelig could be a frontline treatment, rather than a last resort for terminal patients.
The company said “adverse events” were discovered during the trials, but would not say how many patients died or suffered serious side effects.
The TGA said it was reviewing information provided by Gilead and urged patients taking Zydelig to contact their doctor.
Zydelig was first approved in Australia in 2015 for cancer patients who had tried chemotherapy and other treatments without success.
The drug was hailed in the US as a major breakthrough because unlike chemotherapy, the pill targets the cancer without killing healthy cells.=