FDA Rejects AZN's Saphnelo SubQ Formulation, Priority Tag to Datroway

AstraZeneca AZN and its Japan-based partner Daiichi Sankyo announced that the FDA has accepted and granted priority review to their supplemental biologics license application (sBLA) seeking approval of blockbuster antibody-drug conjugate (ADC), Datroway (datopotamab deruxtecan) for expanded use in breast cancer.  

The FDA however issued a complete response letter (CRL) to AstraZeneca’s BLA seeking approval for the subcutaneous (SC) formulation of Saphnelo (anifrolumab), for the treatment of adult patients with systemic lupus erythematosus (SLE). Saphnelo is presently marketed as an IV infusion globally, including the United States, the European Union and Japan for treating moderate-to-severe SLE.

FDA Accepts AZN’s Datroway sBLA for Triple-Negative Breast Cancer

AstraZeneca’s and Daiichi’s sBLA seeks approval of Datroway for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapy.

AZN already markets Datroway globally for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer following prior endocrine therapy and chemotherapy.

The FDA granted a priority review to the application with a target action date expected in the second quarter of 2026.

The application was supported by data from the TROPION-Breast02 phase III study, which demonstrated statistically significant and clinically meaningful improvements in overall survival and reduced the risk of disease progression or death versus chemotherapy when used as first-line treatment. Datroway also delivered a higher objective response rate and duration of response than chemotherapy.

Over the past year, AZN’s shares have surged 29.9% compared with the industry’s 29.1% rise.

Other than in breast cancer, Datroway is also approved in the United States under accelerated approval for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have progressed after EGFR-directed therapy and platinum-based chemotherapy.

Datroway is being evaluated in several late-stage studies globally across multiple cancers, including lung, breast and urothelial cancer.

AstraZeneca and Daiichi Sankyo have been jointly developing and commercializing Datroway under their global collaboration since 2020, with Daiichi Sankyo responsible for manufacturing and supply.

FDA’s CRL to AstraZeneca’s for Saphnelo SC

The FDA issued a CRL on the BLA submitted by AstraZeneca for the subcutaneous formulation of Saphnelo. The BLA submission was based on interim data from the phase III TULIP-SC study, which demonstrated a safety profile consistent with Saphnelo IV infusion.

The company has submitted the requested additional information in the CRL and continues to work closely with the FDA to advance the review. A regulatory decision on the updated application is expected in the first half of 2026.

The Saphnelo SC formulation was approved by the European Commission in December for adult patients with moderate-to-severe SLE.

AZN’s Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the biotech sector are Assertio Holdings ASRT, Alkermes ALKS and Castle Biosciences CSTL, each currently sporting 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 Assertio’s 2026 loss per share have narrowed from 30 cents to 28 cents. ASRT shares have declined 2.6% over the past year.

Assertio’s earnings beat estimates in one quarter and missed in the remaining three quarters, with the average negative surprise being 35.21%.

Over the past 60 days, estimates for Alkermes’ 2026 earnings per share have increased from $1.54 to $1.91. ALKS shares have risen 10.2% over the past year.

Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average earnings surprise being 4.58%.

Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 50 cents. CSTL shares have risen 38.3% over the past year.

Castle Biosciences’ earnings beat estimates in three of the four quarters and missed in the remaining one, 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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