LAZCLUZE™ (lazertinib)
FOR IMMEDIATE RELEASE:
LAZCLUZE™ (lazertinib) Now Available from Onco360 for the First-line Treatment, in Combination with Rybrevant®, of Adult Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Have EGFR Exon 19 Deletions or Exon 21 L858R Mutations
Louisville, KY — August 29, 2024 — Onco360®, the nation’s leading independent specialty pharmacy, has been selected as a pharmacy partner by Johnson & Johnson for LAZCLUZE™ (lazertinib). LAZCLUZE™ is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) approved for the first-line treatment, in combination with RYBREVANT® (amivantamab-vmjw) as a chemotherapy-free regimen, of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions of exon 21 L858R mutations, as detected by an FDA-approved test. This new regimen shows superior progression-free survival versus the traditional standard of care.
“Onco360 is grateful for the opportunity to partner with the Johnson and Johnson team and become a specialty pharmacy provider for LAZCLUZE™,” said Benito Fernandez, Chief Commercial Officer. “We are proud to add this first-line, chemotherapy-free, targeted therapy to our portfolio to treat patients with locally advanced or metastatic EGFR-mutation non-small cell lung cancer.”
Based on data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program, approximately 234,580 patients will be diagnosed with lung cancer in 2024, accounting for 11.7% of all new cancer cases, with approximately 125,070 expected patient deaths from prostate cancer in 2024, accounting for 20.4% of all cancer deaths. The five-year relative survival rate for lung cancer when considering all stages of disease is 26.7%. NSCLC cases make up 80-85% of all lung cancer diagnoses, with 47% having distant metastatic disease at the time of original diagnosis. In the Western hemisphere, 15-20% of all NSCLC patients have EGFR mutations with a five-year relative survival percentage of only 9%.1,2,3,4
LAZCLUZE is manufactured by Janssen Biotech, Inc., part of Johnson & Johnson. The FDA approval is based on positive results from the Phase 3 MARIPOSA study showing RYBREVANT plus LAZCLUZE reduced the risk of disease progression or death by 30 percent versus osimertinib, with a nine month longer median duration of response in patients with EGFR-mutated advanced NSCLC. Patients treated with RYBREVANT plus LAZCLUZE experienced a significantly longer median progression-free survival (PFS) compared to patients treated with osimertinib (23.7 vs. 16.6 months; HR 0.70; 95% CI 0.58-0.85, P<0.001).5
Please read the full Prescribing Information for RYBREVANT®, and the full Prescribing Information for LAZCLUZE™
Media Contact: Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332
References:
- National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed July 9th, 2024: Lung and Bronchus Cancer — Cancer Stat Facts
- American Cancer Society Key Statistics for Lung Cancer. Accessed July 9, 2024: Lung Cancer Statistics | How Common is Lung Cancer? | American Cancer Society
- Tamura T, Kurishima K, Nakazawa K, et al: Specific organ metastases and survival in metastatic non-small cell lung cancer. Mol Clin Oncol 2015 Jan; 3(1):217-221
- Borgeaud M, Parikh K, Banna GL et al: Unveiling the landscape of uncommon EGFR mutations in NSCLC-A systematic review. J Thorac Oncol 2024 Jul; 19(7):973-983
- Cho BC, Lu S, Felip E, et al: Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. N Engl J Med 2024 Jun 26, online ahead of print.