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Bristol-Myers, AstraZeneca Diabetes Drug Dapagliflozin Shows Bladder, Breast Cancer Risk


Patients taking Bristol-Myers Squibb Co. (BMY) and AstraZeneca Plc. (AZN)’s experimental diabetes drug dapagliflozin, shown effective in a two-year study, had more cases of breast and bladder cancers than patients in the control groups, the companies said.

In all the clinical programs, nine breast cancers and nine bladder cancers were seen among 5,478 patients taking dapagliflozin, compared with one breast and one bladder cancer among the 3,156 in control groups, New York-based Bristol-Myers and London-based AstraZeneca said in a statement released today. There was no imbalance in overall cancer risk, the companies said.

Results from a two-year study released yesterday reported that dapagliflozin in combination with metformin, a standard treatment, was safe and effective. Data presented today at the American Diabetes Association meeting in San Diego has been shared with the U.S. Food and Drug Administration, New York- based Bristol-Myers and London-based AstraZeneca said. It will be reviewed in a meeting with an FDA advisory panel on July 19.

“We look at this very seriously,” said Elisabeth Svanberg, the vice president of development for Bristol-Myers, in an interview today.

In preclinical studies in rats and mice, where the animals were given up to 100 times the human dose, dapagliflozin didn’t increase cancer risks, Svanberg said.

“It’s probably a numerical imbalance,” she said. “Those occur in clinical trials.”

Patients on dapagliflozin were more likely to have urinary tract and genital infections than those taking metformin alone, according to the two-year results.

The drug acts on the SGLT-2 pathway, helping patients excrete extra blood sugar in their urine. The breast and bladder don’t express SGLT-2, the companies said in the statement.

http://www.bloomberg.com/news/2011-06-25/bristol-myers-astrazeneca-diabetes-drug-shows-bladder-breast-cancer-risk.html

Full company press release:

http://finance.yahoo.com/news/Investigational-Compound-bw-2430278566.html?x=0&.v=1

Update on Malignancies in the Overall Dapagliflozin Safety Profile

In the overall dapagliflozin clinical program, there was no overall imbalance in malignant tumors. However, there were imbalances in two tumor types in the dapagliflozin clinical trial program. Nine bladder cancers have been observed in 5,478 patients on dapagliflozin and one bladder cancer has been observed in 3,156 patients in control groups. Six of these 10 subjects had hematuria (blood in the urine) at baseline and five were diagnosed within a year after study start. Nine breast cancers have been observed in 2,223 women on dapagliflozin and one has been observed in 1,053 women in control groups. All were diagnosed within a year after study start.

In preclinical studies, dapagliflozin was not shown to be genotoxic or carcinogenic and the investigational agent has no known off-target pharmacology. SGLT2 is not expressed in the breast or in the bladder.

These clinical and preclinical data have been shared with FDA and other health authorities and will be reviewed fully at the scheduled Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on July 19, 2011.