Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

NEW INDICATIONS

Tagrisso Receives New Indication as Adjuvant Therapy for NSCLC with EGFR Mutations

JHOP - February 2021 Vol 11, No 1 - FDA Updates, Lung Cancer

On December 18, 2020, the FDA approved osimertinib (Tagrisso; AstraZeneca) for adjuvant therapy after tumor resection in patients with non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The FDA approved this application 2 months ahead of the FDA goal date and granted it a breakthrough therapy designation.

Osimertinib was previously approved for the first-line treatment of metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, and for the treatment of metastatic NSCLC and EGFR T790M mutation after EGFR tyrosine kinase inhibitor therapy.

The FDA approved the new indication based on a randomized, double-blind, placebo-controlled clinical trial in 682 patients with NSCLC and EGFR exon 19 deletions or exon 21 L858R mutation who had complete tumor resection, with or without previous adjuvant chemotherapy. Eligible patients with resectable (stage II-IIIA) tumors had to have predominantly nonsquamous histology and EGFR exon 19 deletions or exon 21 L858R mutations.

The patients were randomized in a 1:1 ratio to oral osimertinib 80 mg once daily or to placebo after recovery from surgery and standard adjuvant chemotherapy, if used.

The major efficacy outcome measure was disease-free survival (DFS) in patients with stage II to stage IIIA NSCLC. The median DFS was not reached in the osimertinib arm compared with 19.6 months in the placebo arm (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; P <.0001). The secondary efficacy end point was DFS in the overall study population; the median was not reached in the osimertinib arm versus 27.5 months in the placebo arm (HR, 0.20; 95% CI, 0.15-0.27; P <.0001).

The most common (>20%) adverse reactions reported with osimertinib, including laboratory abnormalities, were lymphopenia, leukopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough.

The recommended dose of osimertinib as adjuvant treatment of early-stage NSCLC is 80 mg once daily until disease recurrence or until unacceptable adverse events, or for up to 3 years.

Related Items
Rylaze FDA Approved as Part of a Treatment Regimen for Pediatric Leukemia and Lymphoma
JHOP - August 2021 Vol 11, No 4 published on August 17, 2021 in FDA Updates
FDA Approved Truseltiq for Metastatic Cholangiocarcinoma with the FGFR2 Biomarker
JHOP - August 2021 Vol 11, No 4 published on August 17, 2021 in FDA Updates
2021 Midyear Review: Non–Small-Cell Lung Cancer
2021 Midyear Review: Non–Small-Cell Lung Cancer published on August 11, 2021 in Lung Cancer
FDA Approves Darzalex Faspro plus Pomalyst and Dexamethasone for Multiple Myeloma
Web Exclusives published on August 10, 2021 in FDA Updates
FDA Approves Avapritinib for Advanced Systemic Mastocytosis
Web Exclusives published on August 10, 2021 in FDA Updates
Pembrolizumab plus Lenvatinib Combination Receives Regular Approval for Advanced Endometrial Carcinoma
Web Exclusives published on August 10, 2021 in FDA Updates
Padcev Receives Regular FDA Approval for Locally Advanced or Metastatic Urothelial Cancer
Web Exclusives published on August 10, 2021 in FDA Updates
FDA Alert: Pepaxto (Melphalan Flufenamide) Associated with Increased Risk of Death in Postmarketing Clinical Trial
Web Exclusives published on August 3, 2021 in FDA Updates
Lumakras First FDA-Approved Therapy for Advanced or Metastatic NSCLC with KRAS G12C Mutation
JHOP - June 2021 Vol 11, No 3 published on June 16, 2021 in FDA Updates
Rybrevant First FDA-Approved Therapy for NSCLC with EGFR Exon 20 Insertion Mutations
JHOP - June 2021 Vol 11, No 3 published on June 16, 2021 in FDA Updates
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.