EMA, Regulatory

Puma Biotechnology shares tank after CHMP looks ready to hit a red light on neratinib

Six months after Puma Biotechnology won an FDA OK for its cancer therapy neratinib, the EMA looks like its preparing to throw up a big roadblock into Europe over concerns its regulators have about the drug. And the news immediately triggered another sharp turn for the biotech’s stock $PBYI, which plunged 27% in after-market trading.

Analysts have been fretting over the European decision for months now, noting that a scientific advisory group meeting called by the EMA suggested that Puma faced some broad challenges that extended beyond the evidence of severe diarrhea linked to the drug.

Alan Auerbach, Puma CEO

Today Puma announced that the CHMP notified the company of a negative trend vote, which loosely translated means that they are highly unlikely to get a green light in Europe anytime soon to sell neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.

The company’s statement noted:

CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival (iDFS) benefits observed to-date may lack sufficient clinical relevance.

That will likely make Puma’s journey in search of an approval in Europe much, much longer, while it’s free to sell the drug in the US.

Leerink’s Michael Schmidt noted:

CHMP’s opinion was based on the results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer according to PBYI. In contrast to that, the US FDA Oncologic Drugs Advisory Committee (ODAC) voted 12:4 in favor of FDA approval indicating that the risk-benefit profile of Nerlynx was favorable. The FDA subsequently approved Nerlynx with a broad label in the US which is not limited to certain patient sub-populations.

The debate over grade 3 diarrhea seen in clinical trials excited considerable short interest in the stock, but the FDA’s advisers barely hesitated in urging an approval, with a track record that has long favored adding new options for oncologists and patents whenever possible.

Puma’s shares — always volatile in the back-and-forth debate over the drug’s side effects and its efficacy — dived 27% instantly.


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