(Reuters) – The U.S. Food and Drug Administration (FDA) said on Friday that it had approved Novartis AG’s treatment in combination with a hormone therapy for postmenopausal women, as well as for men, with a form of advanced breast cancer.

The drug, alpelisib, to be marketed under the brand name Piqray, belongs to a class of drugs known as PI3K inhibitors and is the first of its kind to be approved, the FDA said in a statement.

“Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer,” the FDA said.

The combination therapy has been approved to treat hormone receptor positive, HER2-negative breast cancer with mutations of the PIK3CA gene and was fast-tracked under a type of FDA’s pilot program.

Although PIK3CA mutations are the most common genetic change in hormone-receptor positive breast cancer, trials of agents seeking to put a brake on this pathway to tumor growth have largely disappointed so far.

Roche Holding AG, one of the world’s biggest producer of cancer drugs, scrapped its experimental PI3K inhibitor, taselisib, last year, citing limited benefits and serious side effects with the drug.

Separately, Novartis won U.S. approval for its gene therapy, Zolgensma, for spinal muscular atrophy and priced the one-time treatment at a record $2.1 million.

Shares of the drugmaker closed up 3%.


Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D’Silva


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