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Lazcluze FDA Approval History

FDA Approved: Yes (First approved August 20, 2024)
Brand name: Lazcluze
Generic name: lazertinib
Dosage form: Tablets
Company: Johnson & Johnson
Treatment for: Non Small Cell Lung Cancer

Lazcluze (lazertinib) is a kinase inhibitor used in combination with amivantamab for the treatment of EGFR-mutated non-small cell lung cancer.

Development timeline for Lazcluze

DateArticle
Aug 20, 2024Approval FDA Approves Rybrevant (amivantamab-vmjw) Plus Lazcluze (lazertinib) for Patients with EGFR-Mutated Advanced Lung cancer
Jun  3, 2024Late-Breaking Results from PALOMA-2 Study of Subcutaneous Amivantamab in Combination with Lazertinib Show Clinically Meaningful Antitumor Response and Improved Safety Profile in Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Oct 23, 2023Phase 3 MARIPOSA-2 Study Shows RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Given with or without Lazertinib Reduced Risk of Disease Progression or Death by 56 and 52 Percent Respectively in Patients with EGFR-Mutated Non-Small Cell Lung Cancer who Progressed on or after Osimertinib
Oct 23, 2023Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Jun  4, 2023New Long-Term Data from the CHRYSALIS Study Show Median Progression-Free Survival Not Reached after 33.6 Months of Follow-Up with First-Line Use of RYBREVANT® (amivantamab-vmjw) and Lazertinib Combination Therapy in Patients with Treatment-Naïve EGFR-Mutated Advanced Non-Small Cell Lung Cancer
Jul 26, 2022Janssen Announces New Data Supporting Safety and Efficacy of Rybrevant and Lazertinib Combination for Patients with Non-Small Cell Lung Cancer and EGFR Mutations
Sep 19, 2021New Data on Rybrevant (amivantamab-vmjw) in Combination with Lazertinib Show Early Activity in Patients with Non-Small Cell Lung Cancer Whose Disease Has Progressed After Both Osimertinib and Platinum-Based Chemotherapy
May 19, 2021Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer

Further information

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