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Novartis' Piqray Approved in Canada for PIK3CA-Mutated Advanced Breast Cancer

NEW YORK – Novartis announced on Thursday that its PI3K inhibitor alpelisib (Piqray) in combination with fulvestrant has gained marketing approval in Canada as a treatment for postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer.

Patients must also have progressed on an endocrine-based regimen to be eligible for treatment. Regulators decided to approve alpelisib, the first breast cancer drug directed at patients with PIK3CA mutations, based on results of the SOLAR-1 study, which had 10 Canadian sites and included 10 Canadian investigators.

In that Phase III study, the combination of alpelisib and fulvestrant significantly improved median progression-free survival over fulvestrant alone, 11 months versus 5.7 months, in advanced breast cancer patients with PIK3CA mutations;  36 percent of patients saw their tumors shrink on the combination treatment compared to 16 percent on just fulvestrant.

"For Canadian patients living with metastatic breast cancer and this particular mutation, the arrival of alpelisib as a new therapeutic option is promising news because it allows us to offer more treatment options and tailor treatment accordingly," Jan-Willem Henning, an oncologist with the Tom Baker Cancer Centre in Alberta, said in a statement. "This is expected to change the way we practice medicine in this area."

The drug is also unique in that it is approved for men with breast cancer. There are approximately 200 new cases of male breast cancer each year in Canada.

Novartis said in statement that a commercial companion diagnostic for assessing PIK3CA mutations in patients is available, and that it is working to validate and set up testing within centers of excellence in Canada.

Alpelisib plus fulvestrant is approved for the same indication in the US and in Europe. The US Food and Drug Administration has also approved Qiagen's Therascreen PIK3CA RGQ PCR Kit and Foundation Medicine's FoundationOne CDx as companion diagnostics for identifying patients with PIK3CA mutations who may be eligible for alpelisib treatment.