Puma Biotechnology, in a statement, said: “Today’s decision follows a reexamination of the negative opinion announced by the CHMP at its formal meeting with the Company to discuss the MAA on February 23, 2018. The CHMP communicated its intention to hold a final vote at its next meeting.”
The CHMP’s negative vote in February was based on the findings of the phase 3 ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the phase 2 CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.
In July 2017, the US Food and Drug Administration approved the once-daily oral tyrosine kinase inhibitor neratinib (Nerlynx) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.
The US approval was based on the findings of the ExteNET trial which evaluated neratinib following adjuvant trastuzumab treatment.
As per the results of the trial, treatment with neratinib led to a 34% reduction in the risk of invasive disease recurrence or death in comparison to placebo after one year of therapy following treatment with a trastuzumab-based regimen.
The phase 3 trial had randomized 2,840 patients across 41 countries with early stage HER2-positive breast cancer, who had undergone surgery and were subjected to adjuvant treatment with trastuzumab.
Following completion of the trastuzumab adjuvant treatment, patients were randomly grouped to be subjected to extended adjuvant treatment with either neratinib or placebo for duration of one year.
Neratinib, formerly known as PB272 was licensed by Puma Biotechnology from Pfizer in 2011.
Image: Excised human breast tissue, showing a stellate area of cancer 2cm in diameter. Photo: courtesy of John Hayman/Wikipedia.org.