Puma Biotechnology, Inc. PBYI announced that it has submitted a Marketing Authorisation Application (MAA) in the EU for its lead pipeline candidate, neratinib.
The company is looking to get neratinib approved for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with Roche Holding AG’s RHHBY Herceptin (trastuzumab)-based adjuvant therapy.
The submission was based on results of the phase III ExteNET study, which demonstrated that extended adjuvant treatment with neratinib following adjuvant treatment with Herceptin in women with early-stage HER2 positive breast cancer reduced the risk of invasive disease recurrence or death compared to placebo.
A New Drug Application (NDA) in the U.S. is expected to be filed shortly. We remind investors that based on a series of meetings and communications with the FDA, the company had delayed its plan to submit the NDA in mid 2016 in order to incorporate the changes requested by the agency.
We note that the FDA had 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.
Apart from HER2-positive breast cancer, neratinib is also being evaluated for HER2-mutated non-small cell lung cancer, HER2-negative breast cancer with a HER2 mutation, and other solid tumors with a HER2 mutation. The company is also developing an intravenous formulation of the candidate.
Considering that Puma has no approved product in its portfolio at the moment and that neratinib is its lead pipeline candidate, investor focus will remain on updates pertaining to the candidate’s development. Early approval and successful commercialization will prove to be a major boost for the company.
Puma Biotech currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the health care sector are Bristol-Myers Squibb Company BMY and Pfizer Inc. PFE, both sporting a Zacks Rank #1 (Strong Buy).
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