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FDA panel backs Puma's breast cancer drug, with reservations

Side effects concerns could see medicines limited

US Food and Drug Administration FDA

US biotech Puma took a step closer to approval of its breast cancer therapy neratinib after an FDA advisory committee voted in favour of the drug.

The panel voted by 12 to four in favour of approving the drug for reducing the risk of breast cancer recurrence in early-stage (post-surgery) patients with early stage HER2-positive tumours who have previously been treated with Roche's Herceptin (trastuzumab).

Data reviewed by the committee showed that neratinib – a former Wyeth/Pfizer drug - achieved a 33% reduction in the risk that patients would go onto develop recurrent disease within two years. That was considered to be a small but significant benefit, although 95% of patients treated with the drug developed diarrhoea, and in 40% it was serious.

That led to calls at the meeting to limit the use of the drug to women who have taken Herceptin in the past two years, although shares in the company surged regardless as investors grew in confidence that the Los Angeles biotech would secure a positive FDA review, which is due to complete in July.

A number of analysts have suggested neratinib may be approved only in patients with hormone receptor-positive tumours, who were deemed to derive the greatest benefit from the drug. Undeterred by a possible restricted label investors piled into the stock, and shares in the company have more than doubled in the last week.

Analyst Alethia Young of Credit Suisse thinks the drug is now near-certain to get a green light, particularly as the FDA briefing documents published ahead of the meeting showed that the regulator considered the data submitted in support of the marketing application seemed to accept the evidence provided on efficacy and revealed "no big surprises" on tolerability.

The main study filed in support of neratinib was the eight-year ExteNET study, which provided one year of continuous therapy with neratinib after patients completed one year of therapy with a Herceptin-based regimen.

Puma says that diarrhoea seen with the drug tends to be short-lived – generally occurring in the first week or so of therapy – and generally doesn’t recur. It can also be managed using preventive anti-diarrhoeal therapies.

"Despite advances in adjuvant therapy for HER2-positive breast cancer, disease recurrence remains a risk," commented Puma's chief executive Alan Auerbach. "Since there are no effective therapies for patients whose disease recurs, there is an important need for additional options to further reduce the risk of recurrence."

Even if it claims US approval, Puma may find it hard to position neratinib in the market, as in a few days Roche is scheduled to report data from the APHINITY trial of Herceptin plus Perjeta (pertuzumab), which if positive could end up replacing Herceptin alone as the go-to adjuvant therapy for HER2-positive breast cancer.

Article by
Phil Taylor

26th May 2017

From: Regulatory

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