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17-11-2022 | FDA | News


FDA approves durvalumab, tremelimumab, chemo triplet for metastatic NSCLC

Author: Shreeya Nanda


medwireNews: The US FDA has authorized the use of durvalumab plus tremelimumab alongside first-line platinum-based chemotherapy in the metastatic non-small-cell lung cancer (NSCLC) setting.

The decision states that the triplet is indicated for adults with treatment-naïve metastatic disease and no sensitizing EGFR or ALK aberrations.

The efficacy of the triplet regimen was demonstrated in the POSEIDON trial, in which both progression-free and overall survival were significantly prolonged with the addition of durvalumab plus tremelimumab to chemotherapy.

The recommended doses of durvalumab and tremelimumab vary by patient weight, at a respective 1500 mg and 75 mg for those weighing 30 kg or more and 20 mg/kg and 1 mg/kg for those weighing less than 30 kg. In each case the drugs need to be given once every 3 weeks alongside four cycles of platinum-based chemotherapy, followed by maintenance treatment with durvalumab plus chemotherapy every 4 weeks. The FDA also says that a fifth dose of tremelimumab should be given at week 16.

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