Tagrisso Plus Chemo Approved by FDA for EGFR-Mutated NSCLC

The Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) plus platinum-based chemotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test, the agency has announced.

The approval was based on the FLAURA 2 trial, which included 557 patients with EGFR deletion or exon 21 L858R mutation-positive la/mNSCLC who had received no prior systemic therapy for advanced disease. Patients in the study received either Tagrisso and chemotherapy or Tagrisso alone.

Tagrisso plus chemotherapy resulted in a median progression-free survival (PFS; the time a patient lives without their disease spreading or worsening) of 25.5 months versus 16.7 months for standalone Tagrisso. Overall survival (the time a patient lives following treatment, regardless of disease status) results were immature at the time of analysis, the FDA reported, noting that “with 45% of pre-specified deaths for the final analysis reported, no trend towards a detriment was observed.”

The most common side effects with at least 20% incidence in patients receiving the combination treatment included leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin and increased blood creatinine.

According to the FDA, the recommended dose of Tagrisso is 80 mg orally daily with or without food until disease progression or unacceptable toxicity.

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