Shares in Puma Biotechnology declined as much as 24 percent Tuesday after the company announced plans to delay an FDA filing for the experimental breast cancer therapy neratinib, also known as PB272. The drugmaker, which initially expressed plans to submit the therapy for FDA approval in the first half of 2015, now expects to submit marketing application for the drug in the first quarter of 2016.
The company said that it is delaying its FDA submission because it now wants to pursue approval of the therapy in the extended adjuvant treatment of HER2-positive early stage breast cancer instead of the original proposed indication of HER2-positive metastatic breast cancer. Puma noted that it will need to submit preclinical carcinogenicity studies to support the filing for the new indication (for related analysis, read ViewPoints: Puma's loss of momentum doesn’t take a deal off the table, but it could make one less pricey).
Earlier this month, Puma announced top-line results from a mid-stage study of neratinib in combination with paclitaxel for the treatment of first-line HER2- positive locally recurrent or metastatic breast cancer. For related analysis, see ViewPoints: Puma's claws blunted by new neratinib data in HER2 breast cancer?
Puma is also developing neratinib as a treatment for other forms of breast cancer, lung cancer and other malignancies.
For related analysis, read also ViewPoints: Puma's loss of momentum doesn’t take a deal off the table, but it could make one less pricey
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