Puma Biotechnology’s experimental breast cancer therapy Nerlynx has been issued a green light by the US Food and Drug Administration.
The decision allows the firm to market the drug for early-stage breast cancer in patients with HER2-overexpressed/amplified forms of the disease, following treatment with Roche’s Herceptin (trastuzumab).
Nerlynx (neratinib) is the first anti-HER2 treatment to be FDA-approved in this setting, after trials showed a 34 percent reduction in the risk of invasive disease recurrence or death versus placebo following one year of therapy.
Data from the ExteNET trial also demonstrated that, after two years of follow-up, invasive disease-free survival was 94.2 percent in patients treated with the drug compared with 91.9 percent in those receiving placebo.
According to Puma, Nerlynx addresses an unmet medical need given that up to 25 percent of HER2-positive early-stage breast cancer patients treated with Herceptin-based adjuvant therapy experience a recurrence of disease.
"The fear of recurrence is ever present in the minds of most women with breast cancer, from the moment they are diagnosed to long after they finish adjuvant treatment," said Marisa C. Weiss, chief medical officer and founder of Breastcancer.org. “New and effective innovative therapeutic options provide huge hope to patients and their families, giving them a better chance of overcoming breast cancer with a chance for a full life.”
Puma said it expects to launch the drug in the US in September.