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11-05-2018 | FDA | Drug approval | News

approvalsWatch

First-line osimertinib approved for metastatic NSCLC in USA

medwireNews: The third-generation epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor (TKI) osimertinib has been approved by the US FDA for treatment-naïve patients with metastatic non-small-cell lung cancer (NSCLC) harboring common EGFR mutations.

The phase III FLAURA study, on which the approval is based, enrolled 556 patients with advanced NSCLC that was positive for the EGFR exon 19 deletion (del19) or the exon 21 L858R mutation. As shown in the trial, progression-free survival (PFS) was significantly better for participants who were randomly assigned to receive osimertinib than for those given gefitinib or erlotinib, at a median of 18.9 and 10.2 months, respectively. The overall survival results were not mature at the time of analysis.

Commenting on the decision, Medicine Matters advisory board member Lecia Sequist (Massachusetts General Hospital and Harvard Medical School, Boston, USA) told medwireNews that “[t]his is good news for our lung cancer patient population with EGFR [mutations] as it offers us another effective tool to use in first line treatment.”

She added: “The data indicate that osimertinib should be the first-line choice at the current time for patients with L858R and del19 EGFR mutations.”

medwireNews also spoke to medical oncologist H Jack West, from the Swedish Medical Center in Seattle, Washington, USA, about his advice for healthcare professionals who may prefer to hold osimertinib back for the second line.

“The concept of having a potentially effective therapy available in reserve is a powerful driver, but it is very flawed here,” he said.

West explained that the idea that you can add the median PFS with erlotinib to that of second-line osimertinib and achieve same median PFS as with first-line osimertinib ignores the important limitation that osimertinib is a second-line option only for the 50–60% of patients who develop the T790M resistance mutation.

The net result is that if osimertinib is reserved as a second-line therapy, less than half of patients will actually receive it, he emphasized.

“Moreover, the benefit goes beyond that of global PFS,” commented West, noting that osimertinib has better activity against brain metastases than other EGFR–TKIs and in addition is “very well tolerated.”

Acknowledging that even moderately severe side effects become a “real burden” to patients using treatment for a year or longer, he continued: “Both the trial-based data and clinical experience in the real world have shown […] that patients have a far easier time with osimertinib than [with] options like erlotinib or afatinib.”

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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