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

Lorbrena Now FDA Approved for First-Line Treatment of Metastatic NSCLC

JHOP - April 2021 Vol 11, No 2 - FDA Updates, Lung Cancer
Download PDF

On March 3, 2021, the FDA approved a new indication for lorlatinib (Lorbrena; Pfizer), a third-generation ALK inhibitor, for the first-line treatment of patients with non–small-cell lung cancer (NSCLC) and ALK mutation.

The FDA has previously approved lorlatinib based on the CROWN study for the second- or third-line treatment of patients with ALK-positive NSCLC, as detected by an FDA-approved test. This new indication also converts the previous accelerated approval to a full approval.

The expanded indication for lorlatinib was based on the results from the phase 3 CROWN clinical trial, which compared lorlatinib and crizotinib (Xalkori) in treatment-naïve patients with metastatic, ALK-positive NSCLC. The results showed a 72% reduction (hazard ratio, 0.28; 95% confidence interval, 0.19-0.41; P <.0001) in the risk for disease progression or death with lorlatinib versus crizotinib.

“The CROWN data have shown Lorbrena can significantly improve outcomes in the first-line treatment of ALK-positive non-small cell lung cancer, including those who present with brain metastases,” said Benjamin Solomon, MD, Department of Medical Oncology, Peter MacCallum Cancer Centre. “This approval is meaningful for my patients, because we now have a highly effective treatment option that can delay the progression of a typically aggressive disease.”

The most common (≥20%) adverse events of any grade with lorlatinib were edema, weight gain, peripheral neuropathy, cognitive effects, diarrhea, dyspnea, and hypertriglyceridemia. Treatment discontinuation because of adverse events occurred in 6.7% of people.

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.