Johnson & Johnson (NYSE:JNJ) has disclosed that the FDA has granted full approval to its EFGR/MET inhibitor Rybrevant (amivantamab) for the treatment of non-small cell lung cancer (NSCLC).
With this approval, Rybrevant, in combination with chemotherapy (carboplatin-pemetrexed), is now approved as a first-line treatment option for patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. This marks a transition from its initial accelerated approval for a similar indication granted back in May 2021.
Concurrently, J&J revealed that the National Comprehensive Cancer Network (NCCN) has updated its guidelines, recommending the Rybrevant-chemotherapy combination as a preferred first-line regimen for NSCLC patients with EGFR exon 20 insertion mutations.
Both the FDA approval and the NCCN recommendation stem from positive top-line results from the phase III PAPILLON study. This study evaluated the efficacy of Rybrevant in combination with chemotherapy in patients with newly diagnosed advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. Notably, patients receiving the Rybrevant-chemotherapy combination achieved a 61% reduction in the risk of disease progression or death compared to those treated with chemotherapy alone.
Meanwhile, a regulatory filing seeking marketing approval/authorization for a similar indication is currently under review in the European Union. This filing is supported by data from the PAPILLON study, with a final decision expected in the coming months.
J&J’s shares have witnessed a 3.4% increase year to date, in contrast to the industry’s growth of 13.6%.
In the fourth quarter of 2023, J&J submitted two supplemental biologics license application (sBLA) filings with the FDA, seeking approval for combination therapies with Rybrevant in NSCLC patients as first-line and second-line treatments for locally advanced or metastatic disease with EGFR exon 19 deletions (ex19del) or L858R substitution mutations.
The first sBLA, submitted in November, aims for FDA approval of Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) for NSCLC patients with EGFR ex19del or L858R substitution mutations whose disease has progressed after receiving AstraZeneca’s Tagrisso (osimertinib). This filing is supported by data from the late-stage MARIPOSA-2 study, with a similar filing submitted in the EU last November.
The second sBLA, filed in December, seeks the agency’s approval for Rybrevant in combination with oral EGFR-TKI inhibitor lazertinib as a first-line treatment option for adult NSCLC patients with EGFR ex19del or L858R substitution mutations. This submission is based on data from the phase III MARIPOSA study, with a parallel filing submitted in the EU last month.
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