The Food and Drug Administration on July 17 approved Puma Biotechnology's drug Nerlynx to treat early-stage breast cancer patients with a HER2 genetic mutation.
Nerlynx is intended as a follow-up treatment for patients who've had their tumor surgically removed and were initially treated with Roche's cancer drug Herceptin.
HER2-positive breast cancer represents 20 to 25 percent of all breast cancer cases, and about 20 percent of HER2-positive breast cancer patients see their cancer return within five years.
Clinical trial results showed 94.2 percent of patients taking Nerlynx did not experience cancer recurrence or death after two years, compared to 91.9 percent of patients taking a placebo.
Puma expects Nerlynx to hit the market in September.
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