FDA, New Products, Research Institutes

AstraZeneca grabs an FDA OK for its new leukemia drug, to be marketed as Lumoxiti

AstraZeneca $AZN just got another boost for its oncology portfolio. The FDA has whisked through a fast OK for the anti-CD22 drug moxetumomab pasudotox for rare cases of hairy cell leukemia.

The green light comes three years after AstraZeneca first steered toward Phase III after seeing some promising early data. Their big biotech group Medimmune had managed the work on this drug, which came out of the NCI.

The approval is another step up for a cancer research team that has been making some real headway with a group of new drugs that includes Lynparza and Tagrisso. Once upon a time, CEO Pascal Soriot had assessed this drug as a comer, with a potential peak sales figure of up to $1 billion.

But those old peak sales estimates handed out years ago when Pfizer came calling with an unwelcome takeover bid were largely aspirational. Jefferies came up with a more achievable $500 million peak sales figure — which still ranks as a solid plus for AstraZeneca — which has had a tough slog outside of cancer R&D.

AstraZeneca execs turned up at ASCO last summer with the Phase III data in hand, though it was largely overlooked at the time. Researchers noted a 75% objective response rate, a 41% complete response rate, and a 30% durable CR rate — hitting the primary endpoint.

Richard Pazdur

The pharma giant will now dub this drug Lumoxiti, targeting treatment resistant patients with a blood cancer marked by excess production of B cells. Those B cells look hairy under the microscope, which is where this cancer got its name.

“Lumoxiti fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies,” said FDA cancer czar Richard Pazdur. “This therapy is the result of important research conducted by the National Cancer Institute that led to the development and clinical trials of this new type of treatment for patients with this rare blood cancer.”


Image: AstraZeneca CEO Pascal Soriot in Shanghai, March 2018. Imaginechina


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