USA— According to a recent Food and Drug Administration (FDA) communication, Lumoxiti for injection will be permanently discontinued in the US market by August 31, 2023.

The FDA approved Lumoxiti, a CD22-directed cytotoxin, in September 2018 for the treatment of adults with relapsed or refractory hairy cell leukemia (HCL) who had received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

According to AstraZeneca’s letter to healthcare providers, the decision to withdraw Lumoxiti from the US market was motivated by the drug’s extremely low clinical uptake due to the availability of other treatment options.

Complexity of administration, as well as the need for toxicity prophylaxis and safety monitoring, may have contributed to its low uptake. The removal has nothing to do with the drug’s safety or efficacy.

Physicians are advised not to initiate new treatment with Lumoxiti. Other options should be considered, including vemurafenib with or without rituximab as a preferred option and ibrutinib as other recommended regimens.

Innate Pharma paid US$50 million for the US commercial rights to Lumoxiti shortly after it was approved in 2018.

Each year, approximately 1,000 people in the United States are diagnosed with HCL, a blood cancer characterized by an excess of B cells that appear hairy under a microscope (hence the name).

However, Innate returned the rights two years later, citing “lower than expected product sales, compounded by the ongoing COVID-19 pandemic.”

The European Commission revoked Lumoxiti’s marketing authorization in the EU in July at the request of AstraZeneca.

EU clears AstraZeneca’s new severe asthma drug

In another development, AstraZeneca’s first-in-class severe asthma therapy Tezspire has been approved in the EU in a new pen injector formulation suitable for administration by patients themselves.

The green light for the pre-filled, single-use pen version of Tezspire (tezepelumab) comes just four months after the Thymic stromal lymphopoietin (TSLP) inhibitor became the first biologic therapy for severe asthma to be cleared in the EU for use in all patients, and not restricted to those with forms of the disease tied to specific characteristics such as high levels of eosinophils.

AstraZeneca’s head of biopharma R&D Mene Pangalos said the new device would help support the use of Tezspire to treat “a broad population of severe asthma patients.”

The biologic is currently delivered as a pre-filled syringe that is dosed once a month by a healthcare worker, but the new formulation will give patients more control over their treatment.

It is approved in the EU, like its predecessor, for use in patients 12 years of age and older with severe asthma who are not adequately controlled with high-dose inhaled corticosteroids plus another medicinal product.

It is estimated that there are 2.5 million patients worldwide with severe asthma who are uncontrolled, without any phenotypic and biomarker limitation.

The European Union approved the pen injector before the United States, where AZ’s partner Amgen has been selling Tezspire since the beginning of 2022.

In the United States, Amgen reported US$55 million in sales in the third quarter of 2022, bringing its total for the first nine months to US$91 million.

AstraZeneca said it expects a regulatory decision by the FDA on the pre-filled pen in the first half of 2023.

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