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UK's NICE Recommends Takeda's Alunbrig for ALK Inhibitor-Naïve Advanced NSCLC

NEW YORK – The UK's National Institute for Health and Care Excellence on Thursday recommended brigatinib (Takeda's Alunbrig) for advanced non-small cell lung cancer patients with ALK-rearranged tumors who have previously not received an ALK inhibitor.

In a final appraisal document, NICE said that the National Health Service England should make the drug available to lung cancer patients in England, Wales, and Northern Ireland. Takeda said it worked closely with NICE and NHS England in support of this positive recommendation.

NICE recommended the drug based on results from the Phase III ALTA-1L trial, which compared the next-generation ALK inhibitor brigatinib against the first-generation crizotinib (Pfizer's Xalkori) in ALK-positive NSCLC patients with locally advanced or metastatic disease, who had previously not received this class of drugs. Two years of follow-up data showed brigatinib halved the risk of progression or death in patients compared to crizotinib and was significantly better at staving off progression in patients whose disease had spread to the brain.

Within NHS England, ALK-positive, advanced NSCLC patients who have not had an ALK inhibitor before, are first offered alectinib (Genentech's Alecensa). If patients' ALK status is not known, then after chemotherapy they are offered crizotinib. "Brigatinib may be offered as an alternative to these treatments," NICE said.

The agency noted that the data from ALTA-1L suggests brigantinib extends patients' lives more than criztotinib but this is uncertain, and while there is no head-to-head comparison of brigatinib and alectinib, there is indirect evidence suggesting the two drugs have comparable efficacy in delaying progression. "Despite the uncertainty, the most likely cost-effectiveness estimates for brigatinib are within what NICE considers an acceptable use of NHS resources," the agency said. "So, brigatinib is recommended."

NICE also indicated in its final appraisal that Takeda had agreed to provide brigatinib at an undisclosed discount to the drug's £4,900 ($6,515.13) list price.