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22-08-2018 | FDA | News

approvalsWatch

FDA announces approvals for metastatic SCLC, unresectable HCC

medwireNews: US patients with metastatic small-cell lung cancer (SCLC) and those with unresectable hepatocellular carcinoma (HCC) have additional treatment options following recent decisions by the FDA.

The indication for nivolumab has been expanded to include metastatic SCLC that has been treated with platinum-based chemotherapy and at least one other line of therapy.

This accelerated approval is based on the multicohort CheckMate 032 trial, in which 12% of the 109 SCLC patients achieved an objective response. Responses lasted for at least 6 months in 77% of the responders, and for at least 12 and 18 months in 62% and 39%, respectively.

The PD-1 inhibitor should be administered at a dose of 240 mg every 2 weeks.

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The FDA has also given the nod to the multikinase inhibitor lenvatinib for the treatment of patients with newly diagnosed, inoperable HCC.

The agent was shown to be noninferior to sorafenib in terms of overall survival (OS) in the phase III REFLECT trial; the median OS durations were 13.6 months for the 478 participants randomly assigned to receive lenvatinib and 12.3 months for their 476 counterparts given sorafenib.

Additionally, lenvatinib treatment led to significant improvements in other endpoints, such as progression-free survival and objective response rate, relative to sorafenib.

The dosing of lenvatinib is based on bodyweight, such that the dose is 12 mg/day for patients weighing 60 kg or more and 8 mg/day for those with a lower weight.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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