U.S. FDA approves Puma Biotech's breast cancer treatment

(Reuters) - The U.S. Food and Drug Administration (FDA) on Monday approved Puma Biotechnology Inc’s experimental breast cancer drug that lowers the risk of the disease returning after initial treatment.

Shares of Los Angeles-based Puma Biotech jumped 9.7 percent to $94.45 in after-hours trading. The stock has so far more than doubled in value since May when the FDA said in a preliminary review that Puma Biotech’s drug, neratinib, appeared to be effective.

Neratinib — the first treatment of its kind — is designed to treat early-stage breast cancer in patients with the HER2 genetic mutation whose tumor has been surgically removed and who have been treated with Roche’s Herceptin.

After two years, 94.2 percent of patients treated with neratinib had not experienced cancer recurrence or death, compared with 91.9 percent of patients receiving a placebo, the FDA said in a statement on Monday.

Breast cancer is the most frequently diagnosed cancer in women. HER2-positive breast cancer accounts for 20 to 25 percent of all cases.

The current standard of care in patients with early-stage breast cancer is chemotherapy and one year of Herceptin treatment following surgery.

About 20 percent of patients with HER2-positive early breast cancer see their cancer recur within five years following standard treatment.

Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Sai Sachin Ravikumar