Puma Biotechnology, Inc. PBYI announced yet another delay in the new drug application (NDA) filing for its lead pipeline candidate, neratinib (PB272). The company is looking to get neratinib approved for the treatment of extended adjuvant breast cancer in patients who have previously been treated with a regimen containing Roche Holding AG’s RHHBY Herceptin (trastuzumab). We expect investors to react negatively to the news.
On the basis of a series of meetings and communications with the FDA that were recently conducted, the company now plans to submit the NDA in mid-2016 to incorporate changes requested by the FDA. It represents a delay from the previous time-line of the first quarter of 2016. In Dec 2014, the company had pushed out the filing date for neratinib into the first quarter of 2016 from the first half of 2015.
The regulatory agency has requested the company to amend the current statistical analysis plan for the phase III ExteNET study on neratinib to include the rules for censoring data for recurrent disease events or death, following data evaluation.
For the primary endpoint of the study – invasive disease-free survival (iDFS) – the original analysis was based on all recurrent disease events and deaths occurring within two years and 28 days following randomization. The FDA has requested that events (disease recurrence or deaths) observed after missing 2 or more scheduled disease assessments to be censored at the last available disease assessment time prior to the event occurrence. Moreover, a primary analysis approach will be used in the study’s updated statistical analysis plan.
The company said that the updated analysis approach will not considerably affect primary analysis results. While there were 179 iDFS events in the original analysis, the events now stand at 173. In the original analysis, iDFS rates for neratinib and the placebo arm were 93.9% and 91.6%, respectively. Under the updated approach, the numbers are 94.2% and 91.9%, respectively. Moreover, reduction in risk of iDFS of 33% in the original analysis has increased to 34% after update.
Considering that Puma Biotech has no approved product in its portfolio at the moment with neratinib being the company’s lead pipeline candidate, the latest development comes as a major blow for the company.
Puma Biotech is a Zacks Rank #4 (Sell) stock. A couple of better-ranked stocks in the health care sector are Anika Therapeutics Inc. ANIK and AMAG Pharmaceuticals, Inc. AMAG, each carrying a Zacks Rank #1 (Strong Buy).
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