FDA Approves Tagrisso for Some With Advanced NSCLC

Tagrisso was approved by the FDA for certain patients with stage 3 non-small cell lung cancer.

The Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for adults with locally advanced, unresectable (cannot be surgically removed) stage 3 non-small cell lung cancer (NSCLC) whose disease has not progressed (worsened or spread) during or after concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, the agency has announced.

The efficacy of Tagrisso was shown in the LAURA trial of 216 adults with locally advanced, unresectable stage 3 NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who had not progressed on or after definitive platinum-based chemoradiation within 42 days before study randomization, according to the FDA. Patients received 80 milligrams of Tagrisso orally daily or placebo until disease progression or unacceptable toxicity.

Tagrisso, the agency stated, displayed an improvement in progression-free survival (PFS, the time a patient lives without their disease spreading or worsening), with a median PFS of 39.1 months in the Tagrisso group and 5.6 months in the placebo group.

Overall survival (the time a patient lives regardless of disease status) results were not mature at the time of analysis, with 36% of pre-specified deaths for the final analysis reported, but the FDA stated that no trend towards a detriment had been observed.

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The most common side effects, including laboratory abnormalities, occurring in at least 20% of patients were lymphopenia (low count of lymphocytes, a type of white blood cell), leukopenia (low count of leukocytes, a type of white blood cell), interstitial lung disease (scarring of the lung tissue)/pneumonitis (inflammation of the lung tissue), thrombocytopenia (low count of platelets), neutropenia (low count of neutrophils, a type of white blood cell), rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19 infection, the FDA reported.

The agency said that the recommended dose of Tagrisso is 80 milligrams daily, with or without food, until disease progression or unacceptable toxicity.

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