Johnson & Johnson (NYSE:JNJ) has announced the submission of a supplemental biologics license application (sBLA) seeking expanded approval for its cancer drug, Rybrevant (amivantamab-vmjw). The company is seeking approval for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or after treatment with AstraZeneca’s Tagrisso (osimertinib).
The sBLA is supported by data from the phase III MARIPOSA-2 study, which evaluated the safety and efficacy of Rybrevant plus chemotherapy in this specific patient population. Currently, Rybrevant is approved in the United States for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy. The European Medicines Agency has also granted conditional marketing authorization for Rybrevant for the same indication.
Shares of J&J have experienced a 15.1% decline this year, contrasting with the industry’s growth of 3.8%.
In October 2023, the company presented data from the MARIPOSA-2 study at the European Society for Medical Oncology 2023 Congress. The data indicated that the combination of Rybrevant plus chemotherapy demonstrated a significant improvement in progression-free survival, the primary endpoint, compared to chemotherapy alone in patients with EGFR-mutated advanced NSCLC following prior osimertinib therapy.
It’s noteworthy that another sBLA is in progress seeking approval for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertion mutations. Additionally, several early to mid-stage studies are currently underway to evaluate Rybrevant in NSCLC.
Johnson & Johnson continues to explore new avenues for Rybrevant, underscoring its commitment to advancing treatment options for patients with advanced lung cancer.
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