AZN, Daiichi's Enhertu Gets FDA Nod for First-Line Breast Cancer

AstraZeneca PLC AZN and its Japan-based partner Daiichi Sankyo announced that the FDA has approved their blockbuster antibody-drug conjugate (ADC), Enhertu, for first-line use in breast cancer. Enhertu (trastuzumab deruxtecan) is now approved in combination with Roche’s Perjeta (pertuzumab) as first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer in the United States. This approval is based on data from the phase III DESTINY-Breast09 study, followed by a priority review and Breakthrough Therapy designation by the FDA.

The regulatory application for Enhertu was reviewed under the FDA’s real-time oncology review (RTOR) program.

Enhertu is already approved for the second-line treatment of patients with HER2-positive breast cancer in more than 85 countries, including the United States. It is also approved in HER2-targeted indications for lung and gastric cancers.

Following the approval of Enhertu for first-line use in breast cancer, AstraZeneca is entitled to pay Daiichi Sankyo $150 million as a milestone payment.

Over the past year, AZN’s shares have surged 36.3% compared with the industry’s 12.1% rise.

DESTINY-Breast09 Study Data Supports Enhertu’s Expanded Use

In the DESTINY-Breast09 study, the Enhertu-Perjeta combination demonstrated a statistically significant improvement in progression-free survival and reduced the risk by 44% compared with the current standard regimen — taxane chemotherapy combined with Roche’s cancer drugs Herceptin and Perjeta (“THP”) for patients with HER2-positive metastatic breast cancer. The median progression-free survival (PFS) was 40.7 months for patients treated with the Enhertu-Perjeta combo, compared with 26.7 months with THP.

AstraZeneca and Daiichi entered a global collaboration in March 2019 to jointly develop and commercialize Enhertu, followed by an expansion of the partnership in July 2020 to include Datroway (datopotamab deruxtecan). Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. Daiichi records sales of Enhertu in the United States.

AZN’s Zacks Rank & Stocks to Consider

AZN currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Castle Biosciences CSTL. ANIP, CRMD and CSTL currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.54. Over the same period, EPS estimates for 2026 have surged from $7.79 to $8.15. Shares of ANIP have surged 46% in the past year.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD have surged 32.7% over the past year.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 65 cents to 34 cents in 2025. Over the same period, loss estimates for 2026 have improved from $2.10 to $1.06. CSTL stock has rallied 38.2% over the past year.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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