FDA Grants Lung Cancer Drug Accelerated Approval

Osimertinib (Tagrisso) is a once daily tablet for patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.

The FDA today granted accelerated approval to a new breakthrough treatment option for lung cancer.

Osimertinib (Tagrisso) is a once daily tablet for patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or following EGFR tyrosine kinase inhibitor (TKI) therapy.

Osimertinib was previously granted Breakthrough Therapy Designation by the FDA.

The efficacy of the drug was shown in a pair of multicenter, single-arm, open-label clinical trials among patients with metastatic EGFR T790M mutation-positive NSCLC who previously progressed on systemic therapy, including EGFR TKI. All of the 411 patients had EGFR T790M mutation-positive NSCLC as detected by the cobas EGFR mutation test.

Patients in the trial received a daily 80 mg dose of osimertinib.

In the first trial (n=201), patients showed an overall response rate (ORR) of 57% (95% CI: 50%, 64%), while patients in the second trial (n=210) had an ORR of 61% (95% CI: 54%, 68%).

Among both trials, 96% of patients had ongoing responses at primary analysis and the median duration of response was not reached, as the duration of ongoing responses went from 1.1 to 5.6 months following a median follow-up duration of 4.2 months in study 1 and 4 months for study 2.

The most common side effects in both trials were diarrhea (42%), rash (41%), dry skin (31%), nail toxicity (25%), eye disorders (18%), nausea (17%), decreased appetite (16%), and constipation (15%).