FDA approves Rybrevant combo for advanced lung cancer
USA—The U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in conjunction with standard-of-care chemotherapy for adult patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC).
According to Johnson & Johnson, this approval is specifically for patients with cancer that has progressed despite treatment with an EGFR tyrosine kinase inhibitor (TKI) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations.
The most recent approval of RYBREVANT in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) is the third in 2024 alone, demonstrating the drug’s expanding importance in cancer.
The recent FDA approval was driven by data from the Phase 3 MARIPOSA-2 (NCT04988295) study, which assessed the safety and effectiveness of RYBREVANT combined with chemotherapy in patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions or L858R substitution mutations.
These patients had experienced disease progression after receiving Osimertinib.The study’s results demonstrated that the combination of RYBREVANT® and chemotherapy significantly reduced the risk of disease progression or death (progression-free survival, PFS) by 52% compared to chemotherapy alone.
The study’s primary endpoint was progression-free survival, with secondary endpoints including overall response rate and safety outcomes.
The safety profile of RYBREVANT® in combination with chemotherapy was consistent with the known safety profiles of the individual treatments.
Commenting on these findings, Dr. Martin Dietrich, M.D., Ph.D., an oncologist at Cancer Care Centers of Brevard, said that the RYBREVANT®-chemotherapy combination addressed common mechanisms of resistance to third-generation EGFR TKIs like osimertinib.
Dr. Dietrich also added that this combination therapy extended progression-free survival and improved overall response rates, making it an effective new second-line treatment option for patients.
In addition, Andrea Ferris, President and CEO of the LUNGevity Foundation, expressed enthusiasm about the progression-free survival benefits observed in the MARIPOSA-2 study.
She noted that this new therapeutic option combining RYBREVANT® and chemotherapy addresses unmet needs affecting individuals with EGFR-mutated lung cancer, potentially bringing positive change and hope to patients and their families.
Dr. Kiran Patel, Vice President of Clinical Development for Solid Tumors at Johnson & Johnson Innovative Medicine, emphasized the significance of this milestone.
He stated that it reinforces RYBREVANT’s position as a crucial treatment option for patients with EGFR-mutated NSCLC who face high unmet needs after disease progression on or after TKI therapy.
Dr. Patel stressed the importance of providing patients with effective, targeted approaches across all lines of therapy.
The impact of this approval is far-reaching, as RYBREVANT-based regimens have the potential to establish new standards of care for the approximately 30,000 patients diagnosed with EGFR-mutated NSCLC in the United States each year.
This development is particularly critical as RYBREVANT, in combination with chemotherapy, is now the only treatment option designated as Category 1 in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for patients with EGFR-mutated NSCLC who are progressing on osimertinib and are symptomatic with multiple lesions.
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