As core operations at the US Food and Drug Administration (FDA) remain stable despite ongoing shifts in senior leadership, the agency has made some notable decisions in the realm of oncology, with AbbVie’s blood cancer therapy securing approval while AstraZeneca’s breast cancer drug faces an extended review.
In a first for blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare and highly aggressive blood cancer, patients will now be eligible for treatment with an antibody-drug conjugate (ADC), as AbbVie has obtained the regulatory green light for its CD123-targeting therapy, Decnupaz (pivekimab sunirine).
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The FDA approved Decnupaz based on the results of the Phase I/II CADENZA trial (NCT03386513), in which the drug prompted a composite complete response (cCR) in 69.7% and 15.7% of newly diagnosed and relapsed or refractory BPDCN patients, respectively. The drug does come with a boxed warning for liver toxicity.
While a 2025 paper published in Blood notes that the oncology space is yet to establish a standard of care (SoC) conditioning regimen for BPDCN, doctors often treat patients with intensive chemotherapy followed by a stem cell transplant. However, many treated in this way see their cancer return – leaving them with limited treatment options.
According to Naveen Pemmaraju, professor of leukaemia at the University of Texas MD Anderson Cancer Center, Decnupaz could offer “meaningful benefit for BPDCN patients in need of new treatment alternatives”. It also offers a treatment option that can be initiated in the outpatient setting.
Decnupaz will now directly compete for market share with the Menarini Group’s anti-CD123 fusion protein, Elzonris (tagraxofusp), which became the first targeted drug to secure US approval for BPDCN in 2018.
AstraZeneca’s breast cancer drug in limbo
As AbbVie welcomes another addition to its oncology portfolio, the frontline breast cancer approval of AstraZeneca’s anti-oestrogen endocrine therapy, camizestrant, hangs in the balance.
This comes as the FDA requests additional data to inform its regulatory decision, after an advisory committee voted six to three against the drug due to the opponent’s belief that it failed to provide a clinically meaningful benefit. It is important to note that the FDA can choose to override the advisory committee’s decision.
Camizestrant is under review for potential approval alongside a cyclin-dependent kinase (CDK)4/6 inhibitor in hormone receptor (HR)-positive, HER2-negative advanced breast cancer with an emergent ESR1 mutation.
Currently, the SoC treatment for this form of breast cancer combines a CDK4/6 blocker with an aromatase inhibitor. As the latter class of drugs has been linked to treatment resistance, companies are increasingly exploring the promise of next-generation hormonal therapies that can overcome this challenge.
This includes AstraZeneca, which has developed camizestrant to be a next-generation, oral selective oestrogen receptor degrader (SERD) and complete oestrogen receptor (ER) antagonist. Roche is also developing an oral SERD for breast cancer, though the drug failed a Phase III trial in March 2026.
Elsewhere in AstraZeneca’s breast cancer pipeline, its Daiichi Sankyo co-developed ADC, Datroway (datopotamab deruxtecan), recently secured FDA approval for frontline triple-negative breast cancer (TNBC), making it the first TROP2-directed drug in the modality to reach this milestone. Upon this approval, the company beat Gilead to market, which is currently awaiting a regulatory decision for its rival TROP2 ADC, Trodelvy (sacituzumab govitecan), in the indication.
