FDA approves Janssen’s Rybrevant

The US Food and Drug Administration (FDA) has approved Janssen’s Rybrevant as the first treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

In the US, currently available targeted treatments such as EGFR tyrosine kinase inhibitors (TKIs) are not FDA-approved for treating NSCLC driven by EGFR exon 20 insertion mutations.

On top of that, NSCLC driven by this particular mutation often carries a worse prognosis and reduced survival rates compared with lung cancer driven by more common mutations.

"The approval of Rybrevant, along with the companion diagnostic test, addresses high unmet need in the treatment of people with genetically defined non-small cell lung cancer," said Peter Lebowitz, global therapeutic area head, oncology, Janssen Research & Development.

"At Janssen, we are committed to the development of innovative therapies like Rybrevant and believe that advancing medicines targeting specific pathways can bring the greatest benefits and improve outcomes for patients with tumour alterations such as EGFR and MET,” he added.

Rybrevant, a fully-human bispecific antibody, is designed to directly target EGFR and MET receptors.

The FDA approval is based on positive data from the Phase I Chrysalis study, in which Rybrevant-treated patients achieved an overall response rate of 40%, with 4% of patients having complete response and 36% achieving partial responses.

These responses were found to be durable, with median duration of response of 11.1 months, with 20% having responses of at least six months or greater duration.

The median progression-free survival (PFS) was 8.3 months and median overall survival (OS) was 22.8 months.

"Today's FDA approval is an important development for people living with non-small cell lung cancer with exon 20 insertion mutations who, until now, have had no approved treatment options to target their disease," said Jill Feldman, co-founder of the EGFR Resisters, an advocacy organisation patient group, and a lung cancer patient advocate.

"We are excited by the promise this new treatment option brings to people with this particular type of lung cancer and their families,” she added.