EMA, Regulatory

Hit by an expected EMA rejection, Puma plans to appeal negative opinion on neratinib

Exactly a month after warning Puma Biotechnology $PBYI of a negative trend vote regarding neratinib, European regulators have come down with a formal negative opinion for the cancer drug.

Alan Auerbach

In a brief note, Puma told investors that the CHMP has recommended the refusal of the marketing authorization application for neratinib as a treatment of early-stage HER2-positive breast cancer. Given that the European Commission usually follows EMA recommendations, a red light is likely to follow.

All hope is not lost, though, said the LA-based biotech:

The CHMP has noted that Puma may request a re-examination of the opinion and that a letter of intent to seek re-examination should be submitted within 15 days of acknowledgement of receipt of the final opinion package. Puma plans to submit this request in accordance with this timeline.

We saw the roadblock coming. The EMA has raised concerns over the clinical relevance of the data coming out of Puma’s PhII and PhIII studies in extended adjuvant early-stage HER2-positive breast cancer. Combined with the evidence of of severe diarrhea linked to the drug, that led to a negative benefit risk assessment.

Puma won the all-important US approval, though, after agency experts largely gave the biotech a pass on safety issues, preferring to give physicians and patients another drug to consider.

Puma recently out-licensed the drug — marketed as Nerlynx in the US — to Israel’s Medison Pharma and China’s CANbridge Life Sciences. It’s also testing neratinib in a basket of trials in hopes of swiftly expanding its indications in the US.

Puma’s stock slid almost 2% in pre-market trading.


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