FDA Approves Osimertinib for EGFR T790M Mutation-positive NSCLC

Share this content:
The US Food and Drug Administration approved osimertinib for the treatment of EGFR T790M mutation-positive NSCLC.
The US Food and Drug Administration approved osimertinib for the treatment of EGFR T790M mutation-positive NSCLC.

The US Food and Drug Administration (FDA) approved osimertinib for the treatment of EGFR T790M mutation-positive NSCLC, according to a press release.1

The approval is based on the findings of the phase 3 AURA3 study (ClinicalTrials.gov Identifier: NCT02151981), which showed a progression-free survival improvement of 5.7 months over chemotherapy (10.1 months vs 4.4 months, respectively).

The study included 419 patients with metastatic disease who were randomly assigned 2:1 to receive osimertinib 80 mg daily or a platinum-based chemotherapy.

The confirmed objective response rate with osimertinib was 65%, with an estimated median response duration of 11 months. Overall survival data are not yet available.

The most common adverse events observed in patients receiving osimertinib were “diarrhea, rash, dry skin, nail toxicity, and fatigue.” The most common serious adverse event was lung disease/pneumonitis, which occurred in 3.5% of patients.

RELATED: 2016 Oncology Drug Approvals Span Multiple Cancers

Osimertinib is an EGFR tyrosine kinase inhibitor (TKI) manufactured by AstraZeneca Pharmaceuticals.

Reference

  1. Osimertinib (TAGRISSO) [news release]. Silver Spring, MD: US Food and Drug Administration; March 30, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ ApprovedDrugs/ucm549683.htm. Accessed March 30, 2017.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters