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Novartis breast cancer drug wins FDA approval along with QIAGEN diagnostic test

The U.S. Food and Drug Administration approved a combination of Novartis AG's Piqray and endocrine therapy fulvestrant to treat a type of breast cancer in certain patients.

The company's Piqray tablets were approved to be used in combination with FDA-approved fulvestrant, which is sold by AstraZeneca PLC as Faslodex, to treat men and postmenopausal women with hormone receptor-positive, or HR+, human epidermal growth factor receptor-2 negative, or HER2-, breast cancer with a PIK3CA mutation that has grown or spread to other parts of the body and has progressed after hormone therapy.

PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; about 40% of patients with this type of breast cancer have this mutation. These mutations are associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis, according to a May 24 news release.

Piqray targets the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer, Novartis noted.

The FDA approval was based on the results from the late-stage SOLAR-1 study, which showed that the addition of Piqray to fulvestrant increased disease-free survival in patients whose tumors had the PIK3CA mutation to 11 months against 5.7 months with fulvestrant alone.

Additionally, the regulator approved QIAGEN Manchester Ltd.'s therascreen PIK3CA RGQ PCR Kit for use as a companion diagnostic test to detect the PIK3CA mutation in a tissue or a liquid biopsy. Patients who are negative by the therascreen test using the liquid biopsy should undergo tumor biopsy for PIK3CA mutation testing.

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