Osimertinib with chemotherapy is approved by the USFDA for EGFR-mutated non-small cell lung cancer

The Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) in combination with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) who have tumors with EGFR exon 19 deletions or exon 21 L858R mutations, as identified by an FDA-approved test, on February 16, 2024.

The test was done in FLAURA 2 (NCT04035486), a random, open-label study with 557 people who had either EGFR exon 19 deletion or exon 21 L858R mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and had not had any systemic treatment for advanced illness before. Patients were randomly assigned in a 1:1 ratio to receive either osimertinib plus platinum-based chemotherapy or osimertinib alone.

The primary efficacy measure was progression-free survival (PFS), evaluated by the investigator, with overall survival (OS) as a significant secondary measure. When osimertinib was combined with platinum-based chemotherapy, progression-free survival (PFS) was much higher than when osimertinib was used alone. The hazard ratio was 0.62 (95% CI: 0.49–0.79; two-sided p-value<0.0001). The median progression-free survival (PFS) was 25.5 months with a 95% confidence interval (CI) of 24.7 to not estimable (NE) in one arm, and 16.7 months with a 95% CI of 14.1 to 21.3 in the other arm.

Although the overall survival statistics were not fully developed at the current analysis, with just 45% of the pre-specified fatalities reported for the final analysis, there was no indication of a negative trend.

Leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail damage, dry skin, and high blood creatinine levels were some of the most common side effects that happened to people who were given osimertinib along with platinum-based chemotherapy.

The suggested osimertinib dosage is 80 mg taken orally once a day, with or without food, until disease progression or unacceptable toxicity. Consult the prescribing information for pemetrexed with cisplatin or carboplatin for the specific dose details.