FDA signs off on new dosage for Takeda’s lung cancer drug

Takeda Pharmaceutical Co. on Tuesday earned Food and Drug Administration approval for a new dosage of its cancer drug Alunbrig.

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The drug is a second-line treatment for patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer who are already taking Pfizer’s drug crizotinib — the standard treatment for the disease.

Alunbrig, previously offered in 30 milligram tablets only, will now also be available in 180 milligram tablets. Takeda recommends patients take 90 milligrams daily for the first week before increasing to a 180-milligram daily regimen.

“Patients who were taking Alunbrig had to take three pills (to equal 90 milligrams) daily or six pills (to equal 180 milligrams) daily,” said Ryan Cohlhepp, PharmD, vice president of marketing, operations and analytics for Takeda Oncology. “With the approval of a 180 milligram tablet, Alunbrig has become the only ALK inhibitor available as a one tablet per day dose that can be taken with or without food.”

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