FDA Approves AstraZeneca's Truqap/Faslodex Combo Therapy For Breast Cancer, Competes With Gilead's Drug

FDA approves AstraZeneca Plc's AZN Truqap (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). 

Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

Also Read: AstraZeneca's Flagship Cancer Drug Imfinzi Fails On Main Goal In Lung Cancer Trial When Combined With Chemoradiotherapy.

The Truqap combination enters a competitive breast cancer treatment market, including AstraZeneca-Daiichi Sankyo's DSKNY Enhertu and Gilead Science Inc's GILD Trodelvy.

The FDA approval was based on the CAPItello-291 Phase 3 trial results published earlier this year in The New England Journal of Medicine.

In the trial, Truqap in combination with Faslodex reduced the risk of disease progression or death by 50% versus Faslodex alone in patients with tumors harboring PI3K/AKT pathway biomarker alterations (median progression-free survival (PFS) 7.3 versus 3.1 months).

Concurrently, the FDA also approved a companion diagnostic test to detect relevant alterations (PIK3CA, AKT1, and PTEN).

Following this approval in the U.S., Astex Therapeutics is eligible to receive a milestone payment from AstraZeneca on the first commercial sale of the drug in the U.S. and royalties on future sales in line with the agreement between the two companies.

Price Action: AZN shares are up 0.33% at $64.01 during the premarket session on the last check Friday.