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UK price watchdog recommends Nerlynx for early breast cancer in draft guidance

The U.K. National Institute for Health and Care Excellence recommended Puma Biotechnology Inc.'s neratinib as an additional treatment for certain breast cancer patients.

In its draft guidance, NICE recommended the drug for adults with early-stage hormone-receptor positive HER2-breast cancer who have undergone surgery to reduce the risk of their disease returning, and are less than one year from completing treatment with Roche Holding AG's cancer drug Herceptin after surgery.

Neratinib, sold as Nerlynx by Pierre Fabre Medicament SAS, taken daily for one year, is recommended if Herceptin is the only HER2-directed adjuvant treatment patients have received. Adjuvant treatments aim to strengthen the body's immune response and lower the risk of the cancer coming back.

Nerlynx is approved in the U.S. and Europe as an add-on therapy for early-stage HER2 overexpressed breast cancer patients who have already been treated with Herceptin, or trastuzumab.

In April, Puma granted Pierre Fabre a license to develop, manufacture and commercialize any pharmaceutical product containing Nerlynx for $60 million up front.

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Patients who have undergone treatment before surgery to reduce tumor size should still show signs of cancer in tissue samples to be eligible for treatment with Nerlynx.

The U.K. pricing authority's recommendation is based on clinical evidence, which showed that patients who received Nerlynx had less risk of their disease returning when compared to those who took placebo.

NICE added that despite lack of data on the medicine's role in extending patients' survival, the committee concluded that the cost-effectiveness estimates for Nerlynx made it an acceptable use of the National Health Service's resources.

Nearly 50,000 women and 400 men are diagnosed with breast cancer every year in the U.K., while one in five tumors are HER2-positive, according to the report. NICE estimated that about 1,600 people will be eligible for treatment with Nerlynx following adjuvant treatment with Herceptin.

The draft recommendation is open for comments until Aug. 28, which will be considered by the committee at its meeting in September.