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AZ nabs US approval for new leukaemia drug Lumoxiti

Adds to firm's growing oncology franchise

AstraZeneca has chalked up another product approval in its oncology franchise, getting an FDA nod for Lumoxiti, a new CD-22-targeted drug for rare cancer hairy cell leukaemia (HCL).

Lumoxiti (moxetumomab pasudotox-tdfk) is the first new treatment for this type of leukaemia in 20 years, according to AZ. It has been approved for adults with relapsed or refractory HCL who have been treated with at least two prior rounds of  systemic therapy after a priority review from the US regulator.

The CD22-directed antibody-drug conjugate (ADC) – which seeks out an destroys cells bearing the CD22 transmembrane protein – is one of the lead candidates in AZ’s R&D portfolio of targeted cancer drugs, along with BTK inhibitor Calquence (acalabrutinib) for B-cell malignancies which picked up its first approval last year.

It has assumed greater importance for the targeted pipeline – which sits alongside AZ’s immuno-oncology R&D – since MEK Inhibitor selumetinib failed late-stage trials in thyroid cancer and lung cancer. However, AZ has two other targeted drugs – PARP inhibitor Lynparza (olaparib) for breast and ovarian cancer and EGFR blocker Tagrisso (osimertinib) – still in the growth phase.

Lumoxiti has been approved based on the results of a phase III study showing an overall response rate of 75% with the drug, with around a third (30%) of patients achieving a “durable complete response”, according to the drugmaker.

“While many patients with hairy cell leukaemia experience a remission with current treatments, 30% to 40% will relapse five to ten years after their first treatment,” said Robert Kreitman of the National Cancer Institute (NCI) in the US, the lead investigator in the study. The drug grew out of research originally conducted at NCI.

“With subsequent treatments, durations of response diminish and toxicities accumulate, and few approved treatment options exist,” he added. “Moxetumomab pasudotox represents a promising non-chemotherapeutic agent for HCL, addressing an unmet medical need for physicians and their patients.”

At one point AZ was predicting potential sales of $1bn for the drug, and although analysts at Jefferies have suggested that $500m is a more realistic target that would still be a useful addition to the company’s targeted cancer product line.

The approval is also remarkable because it adds to the small stable of ADCs that have been approved for marketing, along with Pfizer’s Mylotarg (gemtuzumab ozogamicin) for acute myeloid leukaemia, Seattle Genetics/Takeda’s classical Hodgkin lymphoma therapy Adcetris (brentuximab vedotin) and Roche’s Kadcyla (trastuzumab emtansine) for breast cancer.

Despite dozens of candidates entering clinical trials, ADCs have been plagued by safety and efficacy issues, often related to the stability of the conjugate in the body. Lumoxiti is AZ’s first ADC product.

Article by
Phil Taylor

14th September 2018

From: Marketing

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