The U.S. Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc (NASDAQ:AZN) and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for patients with a certain type of breast cancer.
The approval covers the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
The approval follows Priority Review and Breakthrough Therapy Designation by the FDA and is based on the results of the DESTINY-Breast09 Phase 3 trial.
In the trial, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab, and pertuzumab (THP).
Median progression-free survival (PFS) was 40.7 months with Enhertu plus pertuzumab compared to 26.9 months for THP.
The PFS benefit for Enhertu plus pertuzumab versus THP was consistent across subgroups.
Financial considerations
Following this approval in the U.S., an amount of $150 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the first-line unresectable or metastatic HER2-positive breast cancer indication.
Daiichi Sankyo recognises sales of Enhertu in the U.S.
On Tuesday, the European Commission approved AstraZeneca's Saphnelo (anifrolumab) for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.
The approval follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion and is based on the Phase 3 TULIP-SC trial results.
In the trial, subcutaneous administration of Saphnelo led to a statistically significant and clinically meaningful reduction in disease activity compared with placebo in participants with moderate-to-severe, active, autoantibody-positive SLE while receiving standard therapy.
Financial considerations
AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. in 2004.
The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb & Co (NYSE:BMY) in 2009.
Under the agreement, AstraZeneca will pay Bristol-Myers a low- to mid-teens royalty on sales, depending on geography.
AZN Price Action: AstraZeneca shares were down 1.03% at $90.62 at the time of publication on Tuesday, according to Benzinga Pro data.
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