The injection Lumoxiti, which was approved for patients with relapsed or refractory hairy cell leukemia, will be pulled from the U.S. market later this year, although alternative therapies are available.
The drug Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of patients with relapsed or refractory hairy cell leukemia, a rare type of the disease, will be withdrawn from the U.S. market by AstraZeneca, the manufacturer of the injection.
A recent notification from the Food and Drug Administration (FDA) alerted health care professionals and caregivers of the company’s decision to permanently discontinue the drug in the U.S. on Aug. 31, 2023.
AstraZeneca previously sent a letter to health care providers informing them of the company’s decision to permanently discontinue Lumoxiti from the U.S. market.
“There has been a very low clinical uptake of Lumoxiti since FDA approval on Sept. 13, 2018, due to the availability of other treatment options and possibly due to the specialized complexity of administration, toxicity prophylaxis (actions taken to prevent side effects) and safety monitoring needs for patients,” according to the letter sent by AstraZeneca.
The FDA approved Lumoxiti in September 2018 for the treatment of patients with relapsed or refractory hairy cell leukemia who previously received at least two systemic therapies including a purine nucleoside analog. Of note, a purine nucleoside analog is a type of anticancer drug that uses the natural chemical compound purine to produce the chemical building blocks of DNA and RNA.
The letter from AstraZeneca to health care providers also provided action points for prescribers, including the fact that patients currently being treated with Lumoxiti will have ample time to complete six cycles of the treatment.
Alternative existing therapies are available to mitigate the potential impact of this withdrawal, according to the health care provider letter. Of note, other options include vemurafenib with or without Rituxan (rituximab), which is the preferred option, and Imbruvica (ibrutinib). The letter also lists other options for progressive disease after second-line therapy include single-agent Rituxan, bendamustine plus Rituxan, splenectomy or other therapies.
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