In a letter shared with healthcare providers, AstraZeneca has announced that it will be pulling its leukemia antibody-drug conjugate Lumoxiti (moxetumomab pasudotox-tdfk) from the U.S. market later this year.
Distributors have been instructed to return packages of the drug starting in August and physicians have been advised against prescribing the drug to new patients. This would ensure a more effective market withdrawal in July.
This would also mean that patients who are currently using the drugs will be able to complete all 6 drug cycles before distribution is stopped.
The reason why the CD22-directed immunotoxin drug is being pulled from the market has less to do with safety and efficacy issues relating to the drug, and more with poor sales performance, the pharma company clarified in their letter.
The fact that there is stiff competition present in the market -Johnson & Johnson’s Imbruvica and Roche’s Rituxan and Zelboraf- and that Lumoxiti is an intravenous drug and therefore, a bit complex to monitor are just some of the reasons for disappointing sales figures. The safety monitoring needs for patients were also a concern, the drug infamously came with a boxed warning about capillary leak syndrome and hemolytic uraemic syndrome.
AstraZeneca has said that there has been a very low intake of the drug since its approval by the FDA, which can be credited to the availability of alternative drug treatments available as well as the specialized complexity of administration, toxicity prophylaxis, and safety monitoring needs.
French biotech Innate Pharma announced it was handing back U.S. and European Union commercialization rights in late 2020. This was the first red flag for the company. Innate had first gained the license to the drug from AstraZeneca in 2018 and only 15 months later the company pulled out from the commercialization deal.
Despite the fact that there were initially high hopes for sales, UK-based Cambridge’s chief executive, Sir Pascal Soriot even suggested that the treatment has the potential to gain blockbuster status, but the drug only brought $1 million in sales for Innate in the first half of 2021. Upon its approval analysts from Jefferies had predicted that at its height peak sales from the drug could reach up to $500 million which was still considered a fairly modest amount.
Innate chief executive Mondher Mahjoubi said the company “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.”
The infused checkpoint inhibitor was first approved by the Food and Drug Administration in the U.S. in 2018 to treat patients with relapsed or refractory hairy cell leukemia (HCL) on the condition that these patients had received at least two prior therapies, including purine nucleoside analog (PNA). In 2013 the drug was given orphan status and only two years ago the use of the rare blood cancer treatment drug was discontinued in Europe. The same is now being done in the U.S.