Janssen Submits Supplemental Biologics License Application To U.S. FDA Seeking Approval Of RYBREVANT Plus Chemotherapy For The Treatment Of Patients With EGFR-Mutated Non-Small Cell Lung Cancer Who Progressed On Or After Osimertinib
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Janssen, part of Johnson & Johnson, submitted a supplemental Biologics License Application to the FDA for RYBREVANT combined with chemotherapy to treat EGFR-mutated non-small cell lung cancer post-osimertinib. The submission is based on Phase 3 MARIPOSA-2 study results, which showed improved progression-free survival compared to chemotherapy alone. The study was presented at the ESMO 2023 Congress and published in Annals of Oncology. RYBREVANT previously received accelerated FDA approval for NSCLC with EGFR exon 20 insertion mutations.
November 20, 2023 | 1:15 pm
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Janssen, a Johnson & Johnson company, submitted an sBLA to the FDA for RYBREVANT in combination with chemotherapy for EGFR-mutated NSCLC. Positive study results could lead to expanded treatment options and potentially increase RYBREVANT's market.
The submission of the sBLA by Janssen for RYBREVANT is a significant regulatory step that could lead to expanded use of the drug, potentially increasing its market share and revenue for JNJ. The positive results from the MARIPOSA-2 study support the application and may positively influence the FDA's decision, which could have a favorable impact on JNJ's stock in the short term.
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