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Friday, January 13, 2023

Low uptake prompts AstraZeneca to withdraw Lumoxiti from US market

 AstraZeneca (LSE: AZN) is to pull its leukemia antibody-drug conjugate Lumoxiti (moxetumomab pasudotox-tdfk) from the US market later this year.

Poor sales performance of the CD22-directed immunotoxin drug, rather than any issues with safety, has been cited by the Anglo-Swedish pharma major as the reason for the move.

Lumoxiti was approved by the US Food and Drug Administration in 2018 to treat patients with relapsed or refractory hairy cell leukemia who have received at least two prior therapies.

AstraZeneca has suggested that reasons for the poor take-up could be other drugs being available, the complexity of administration for a product that is intravenously administered and also safety monitoring needs for patients, since Lumoxiti’s label came with a boxed warning about capillary leak syndrome and hemolytic uraemic syndrome.

The signs that all was not rosy with Lumoxiti emerged in late 2020 when French biotech Innate Pharma (Euronext: IPH) announced it was handing back US and European Union commercialization rights.

AstraZeneca had initially out-licensed the drug to Innate in October 2018. At that time, hopes were high for sales. Sir Pascal Soriot, chief executive of the Cambridge, UK-based company, said that he thought the treatment could achieve blockbuster status, while analysts suggested a more modest, although still significant, $500 million in peak revenues.

Innate chief executive Mondher Mahjoubi said the firm had “determined that there is low strategic value for us in maintaining Lumoxiti in our portfolio due to lower than anticipated product sales, further compounded by the ongoing COVID-19 pandemic.”

https://www.thepharmaletter.com/article/low-uptake-prompts-astrazeneca-to-withdraw-lumoxiti-from-us-market

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