Janssen seeks European approval for RYBREVANT in advanced NSCLC 

BELGIUM – Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, has taken a step towards addressing advanced non-small cell lung cancer (NSCLC) by filing a Type II extension of indication application with the European Medicines Agency (EMA) for RYBREVANT (amivantamab).  

This therapy, in combination with lazertinib, aims to revolutionize first-line treatment for adult NSCLC patients with specific epidermal growth factor receptor (EGFR) mutations. 

RYBREVANT, a fully-human EGFR-MET bispecific antibody, exhibits immune cell-directing activity and targets tumors with activating and resistance EGFR mutations, as well as MET mutations and amplifications. 

 The submission to the EMA is based on compelling data from the Phase III MARIPOSA clinical trial, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients receiving the amivantamab-lazertinib combination regimen compared to osimertinib. 

The MARIPOSA trial, which enrolled 1,074 subjects, evaluated the efficacy and safety of amivantamab plus lazertinib versus osimertinib or lazertinib alone. 

 Secondary endpoints included response rate, duration of response, second PFS, and intracranial PFS.  

Importantly, the combination therapy demonstrated a favorable safety profile, with most adverse events being Grade 1 or 2. 

This development follows Janssen’s previous filing of a marketing authorization application for lazertinib plus amivantamab with the EMA, underscoring the company’s commitment to advancing innovative therapies for NSCLC. 

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 In addition, Janssen has sought approval from the US Food and Drug Administration (FDA) for a RYBREVANT combination regimen for locally advanced or metastatic NSCLC. 

RYBREVANT has already made significant strides in the European Union, receiving conditional marketing authorization in December 2021 for the treatment of advanced NSCLC in adults with EGFR exon 20 insertion mutations, post-failure of platinum-based treatment. 

 Notably, it became the first approved treatment in the EU specifically targeting EGFR exon 20 insertion mutations for NSCLC, offering hope to patients in need of effective treatment options. 

Kiran Patel, Vice President of Solid Tumors Clinical Development at Janssen, said there was optimism about the potential of RYBREVANT in transforming first-line treatment for patients with EGFR-mutated NSCLC. “The submission is a testament to our steadfast dedication to advancing innovative therapies for those who need them most, now and in the future. 

He added that the company was by far dedicated to advancing innovative therapies and improving outcomes for patients battling this devastating disease. 

“Pending approval, this novel combination of amivantamab and lazertinib has the potential to transform first-line treatment for patients with EGFR-mutated NSCLC.” he revealed.   

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