Puma Biotechnology Sinks On Breast Cancer Drug NDA Delay

Published: Dec 04, 2014

Puma Biotech Sinks On Breast Cancer Drug NDA Delay

December 3, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

California-based Puma Biotechnology, Inc. announced today that the timeline for filing its New Drug Application for PB272 will be pushed back from the first half of 2015 to the first quarter of 2016.

The NDA filing is for the PB272 drug, also known as neratinib, designated for the extended adjuvant treatment of HER2-positive early stage breast cancer. The company was going to use feedback from various regulatory agencies for the NDA, set to be filed in early 2015. Now, Puma will be adjusting its NDA to include data from preclinical carcinogenicity studies in accordance with International Conference on Harmonization guidelines, resulting in a delay.

PB272 and Its Positive Results
In November, Puma revealed the results of the NEfERTT trial that looked at PB272 for the treatment of first-line HER2-positive locally recurrent or metastatic breast cancer. The trial was a randomized, two-arm Phase II trial that enrolled 479 patients from 33 countries. Individuals had locally recurrent or metastatic breast cancer and had not received prior anticancer therapy for locally recurrent or metastatic disease.

After the study, researchers were able to conclude that PB272 was able to statistically reduce incidences of central nervous system metastases.

“We are very pleased with the results of the NEfERTT trial with neratinib,” said Alan Auerbach, chief executive officer and president of Puma. “As expected, there was no statistically significant difference in progression free survival and objective response rate for the paclitaxel plus neratinib arm compared to the paclitaxel plus trastuzumab arm. However, the paclitaxel plus neratinib arm showed a statistically significant decrease in the incidence of CNS metastases compared to the paclitaxel plus trastuzumab arm. This represents the first randomized trial with a HER2 targeted agent that has shown a statistically significant reduction in the incidence of CNS metastases, which we believe provides a meaningful point of differentiation for neratinib in the treatment of HER2 positive breast cancer.”

Treatment with the combination of paclitaxel plus neratinib resulted in a 52.6 percent reduction in the incidence of central nervous system metastases. The incidence of CNS metastases was 7.4 percent in patients who received this combination treatment. However, the rate was 15.6 percent in patients who received paclitaxel and trastuzumab. The most frequently cited adverse effect associated with paclitaxel and neratinib was diarrhea.

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