The US Food and Drug Administration (FDA) has approved Puma Biotechnology’s supplemental New Drug Application (sNDA) for neratinib plus capecitabine, to treat a type of breast cancer.

The US regulatory agency has indicated neratinib in combination with capecitabine for metastatic HER2-positive breast cancer in adult patients, who have received two or more anti-HER2-based regimens in the metastatic setting before.

Puma CEO and president Alan Auerbach said: “Although there have been many new treatment options for patients with HER2-positive breast cancer, patients still need additional treatment options once they progress.

“Based on the results of our NALA data, we believe NERLYNX could be a promising therapeutic opportunity for these patients.”

Puma said that the sNDA approval was supported by the results from Phase 3 NALA trial, which evaluated the neratinib in combination with capecitabine.

NALA is a randomised, multicentre, open-label, Phase 3 clinical trial, involving 621 metastatic HER2-positive breast cancer patients, treated earlier with two or more anti-HER2-based regimens. The study showed positive results for neratinib plus capecitabine.

Neratinib has been approved in the US for treating adult patients with early-stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy, and is approved in Europe for early-stage hormone receptor-positive HER2-overexpressed/amplified breast cancer.

Also, the drug has been approved in Canada, Australia, Hong Kong, Singapore and Argentina, for use in the extended adjuvant setting.

Puma obtained license for NERLYNX (neratinib) from Pfizer in 2011

In 2011, Puma signed a licensing agreement with Pfizer for the development and commercialisation of Neratinib.

NALA trial investigator Adam M Brufsky said: “Together with the NALA investigators around the world, I am pleased to see the FDA approval of NERLYNX for the treatment of advanced HER2-positive metastatic breast cancer.

“This approval is based on data from the NALA trial, which we presented at ASCO last year, demonstrating that neratinib in combination with capecitabine offers a significant improvement over currently available therapies in this heavily pretreated patient population and can be added to NERLYNX’s established role in the treatment of early breast cancer.”