Regulatory milestones approvals, filings & regulatory actions · 4 recorded
Milestone
Jurisdiction
Brand
Indication
Date
Sentence it was read from
Filednon-small cell lung carcinoma1 milestone
Filed
EU (EMA)
RYBREVANT
non-small cell lung carcinoma
2023-12-21
“today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of lazertinib, in combination with RYBREVANT®” jnj.com ↗
“A marketing authorization application (MAA) and type II extension of indication application weresubmittedto the European Medicines Agency (EMA) seeking approval of LAZCLUZE™” jnj.com ↗
“application (MAA) and type II extension of indication application were also submitted to the EMA seeking approval of lazertinib in combination with RYBREVANT®” jnj.com ↗
At a median follow-up of 37.8 months, RYBREVANT®plus LAZCLUZE®showed a statistically significant reduction in the risk of death compared to osimertinib (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.61-0.92, P=0.005).
Head-to-head comparison data versus osimertinib showed RYBREVANT®(amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.
Median overall survival improvement projected to exceed one year with much-anticipated overall survival analysis showing statistically superior result versus osimertinib
European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The chemotherapy-free combination regimen met the final pre-specified secondary endpoint of OS and demonstrated clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib.
This approval by the European Commission offers the potential to broaden first-line treatment options and provide a new standard of care for eligible patients.
European Commission approves RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the Marketing Authorisation (MA) for LAZCLUZE®▼ (lazertinib), in combination with RYBREVANT®▼ (amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.
With this milestone, RYBREVANT®plus LAZCLUZE™ becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.
SC amivantamab was associated with significantly lower rates of infusion-related reactions (IRRs) and shorter treatment time compared with the IV formulation.
Results from the new analysis show the RYBREVANT®combination consistently and significantly improved progression-free survival (PFS) compared to osimertinib in patients with NSCLC with EGFR exon 19 deletion (ex19del) or L858R mutations.
Study results showed non-inferior efficacy and pharmacokinetics for SC amivantamab combined with lazertinib compared to intravenous (IV) administration, the currently approved formulation of RYBREVANT®(amivantamab-vmjw).
Study results showed non-inferior efficacy and pharmacokinetics for SC amivantamab combined with lazertinib compared to intravenous (IV) administration, the currently approved formulation of RYBREVANT ® (amivantamab-vmjw).
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II extension of indication application to the European Medicines Agency (EMA) seeking approval of RYBREVANT®▼ (amivantamab), in combination with lazertinib
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of lazertinib, in combination with RYBREVANT®▼(amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.
Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)
Results also showed that the two RYBREVANT®regimens significantly improved objective response rate (ORR), intracranial progression-free survival (PFS), and duration of response (DOR) compared to chemotherapy alone in these patients.
With the combination of RYBREVANT and lazertinib in the MARIPOSA study, progression-free survival was significantly improved in patients with previously untreated EGFR-mutated NSCLC compared to osimertinib.
Three Phase 3 RYBREVANT® (amivantamab-vmjw) studies (MARIPOSA, MARIPOSA-2 and PAPILLON) in EGFR-mutated lung cancer achieved statistically significant and clinically meaningful progression-free survival endpoints and will be presented in Presidential Symposium sessions
The pivotal Phase 3 MARIPOSA study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT®plus lazertinib compared to osimertinib.
The pivotal Phase 3 MARIPOSA study met its primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients receiving RYBREVANT® plus lazertinib compared to osimertinib.
The combination of RYBREVANT®and lazertinib with chemotherapy yielded an objective response rate of 50 percent, with 11 out of 20 patients remaining on treatment.
Data presented at WCLC showed combining RYBREVANT ®, lazertinib and chemotherapy may address the diverse resistance that emerges after disease progression on osimertinib
After a median follow-up of nearly three years (33.6 months), the median duration of response (DOR), median progression-free survival (PFS) and overall survival (OS) were not yet reached.
After a median follow-up of 7.1 months, the combination of RYBREVANT®and lazertinib with carboplatin and pemetrexed yielded an overall response rate (ORR) of 50 percent (95 percent confidence interval [CI];27-73), with 15 out of 20 patients remaining on treatment.
After a median follow-up of 7.1 months, the combination of RYBREVANT® and lazertinib with carboplatin and pemetrexed yielded an overall response rate (ORR) of 50 percent (95 percent confidence interval [CI];27-73), with 15 out of 20 patients remaining on treatment.
The analysis showed higher activity and longer duration of response (DOR) in patients treated with the combination therapy, demonstrating the potential benefit of targeting theextracellular (outer) and catalytic (internal) domains ofEGFR, even in patients with documented resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs).
While previously reported results have demonstrated durable responses with RYBREVANT®in combination with lazertinib in chemotherapy-naïve patients previously treated with osimertinib, these new data suggest that intervening chemotherapy does not impact activity with the combination.
The analysis showed higher activity and longer duration of response (DOR) in patients treated with the combination therapy, demonstrating the potential benefit of targeting the extracellular (outer) and catalytic (internal) domains of EGFR, even in patients with documented resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs).
While previously reported results have demonstrated durable responses with RYBREVANT® in combination with lazertinib in chemotherapy-naïve patients previously treated with osimertinib, these new data suggest that intervening chemotherapy does not impact activity with the combination.
Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer