Janssen seeks FDA approval for lung cancer therapy regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking US Food and Drug Administration (FDA) approval for a Rybrevant (amivantamab-vmjw) combination regimen for locally advanced or metastatic non-small cell lung cancer (NSCLC).

It has filed a supplemental biologics licence application (sBLA) with the FDA for the usage of Rybrevant plus chemotherapy to treat NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution.

The company is seeking approval for patients who have progressed on or following treatment with osimertinib.

The chemotherapy regimen comprises carboplatin and pemetrexed.

The sBLA is supported by findings from the Phase III MARIPOSA-2 clinical trial which evaluated the safety and efficacy of the combination therapy.

Data showed that Rybrevant plus chemotherapy offered improvement in progression-free survival versus chemotherapy alone, a primary endpoint of the trial.

A fully human bispecific antibody, Rybrevant is already approved by the FDA for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who have progressed on or following platinum-based chemotherapy.

Janssen research and development solid tumours clinical development vice-president Kiran Patel stated: “New treatment options are urgently needed in the post-osimertinib setting, where patients continue to face unacceptable survival rates. 

“As we strive to transform the standard of care in patients with EGFR-mutated NSCLC, we are committed to working closely with the FDA during review of this submission for Rybrevant in this expanded patient population.”

In October 2023, the company sought the European Medicines Agency’s approval for Rybrevant plus chemotherapy for adults with advanced NSCLC with EGFR exon 20 insertion mutations.

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