The application was based on the results from the Phase 3 PAPILLON trial in which the Rybrevant combination showed a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy alone
Janssen seeks approval for Rybrevant combo as the first-line treatment for NSCLC patients. (Credit: Vysotsky (Wikimedia))
The Janssen Pharmaceutical Companies of Johnson & Johnson has filed a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) to secure approval of Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) to treat adult patients with a type of lung cancer.
Janssen seeks approval for the Rybrevant combo as the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
The sBLA is currently being reviewed by the FDA via the Real-Time Oncology Review (RTOR) programme.
The application was based on the results from the Phase 3 PAPILLON clinical trial, whose results were announced in July this year.
Janssen said that the randomised, open-label study assessed the efficacy and safety of Rybrevant in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
According to the results, the PAPILLON study met its primary endpoint as Rybrevant in combination with chemotherapy produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy alone.
Additionally, the combination showed a safety profile that was consistent with previous reports for each agent.
Janssen Research & Development solid tumours clinical development vice president Kiran Patel said: “PAPILLON is the first randomised Phase 3 study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results.
“This creates an opportunity to make a significant improvement to the standard of care for this patient population with high unmet medical needs.
“We look forward to working with the FDA through the RTOR pathway in pursuit of an approval for Rybrevant plus chemotherapy as we simultaneously progress the development of this novel bispecific antibody in additional patient populations.”
The drug earned accelerated approval in 2021 after receiving Breakthrough Therapy Designation from the US FDA in 2020 as the first fully human, bispecific antibody for the treatment of patients with NSCLC.
The sBLA submission for Rybrevant aims to meet the regulatory requirements of the accelerated approval, validating the clinical benefit seen in the Phase 1 CHRYSALIS study.