Janssen, a pharmaceutical company, has recently submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for the use of RYBREVANT® in combination with chemotherapy as a first-line treatment for patients with EGFR exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC). This submission is based on promising results from a Phase 1b trial that demonstrated the potential of this combination therapy in improving outcomes for patients with this specific type of lung cancer.
EGFR exon 20 insertion mutations are a rare genetic alteration found in approximately 1-2% of NSCLC cases. These mutations are notoriously difficult to target with traditional EGFR inhibitors, which have shown limited efficacy in this patient population. As a result, there is a significant unmet need for effective treatment options for these patients.
RYBREVANT® (amivantamab) is an investigational bispecific antibody that targets both EGFR and MET pathways, two key signaling pathways implicated in the growth and progression of NSCLC. By simultaneously blocking these pathways, RYBREVANT® has the potential to provide a more comprehensive and effective treatment approach for patients with EGFR exon 20 insertion mutation-positive NSCLC.
The Phase 1b trial that forms the basis of Janssen’s FDA submission evaluated the safety and efficacy of RYBREVANT® in combination with chemotherapy in previously untreated patients with EGFR exon 20 insertion mutation-positive NSCLC. The results showed promising activity, with an objective response rate (ORR) of 40% and a disease control rate (DCR) of 88%. These response rates are encouraging, considering the historically poor outcomes associated with this specific mutation.
Furthermore, the combination therapy demonstrated a manageable safety profile, with adverse events consistent with those expected from EGFR inhibitors and chemotherapy. The most common side effects observed were rash, infusion-related reactions, and nausea. These findings suggest that the combination of RYBREVANT® and chemotherapy could be a well-tolerated treatment option for patients with EGFR exon 20 insertion mutation-positive NSCLC.
If approved by the FDA, RYBREVANT® in combination with chemotherapy would represent a significant advancement in the treatment landscape for this specific patient population. Currently, there are no approved targeted therapies specifically indicated for EGFR exon 20 insertion mutation-positive NSCLC, leaving patients with limited treatment options.
The potential approval of RYBREVANT® would provide healthcare professionals with a new tool to effectively manage this challenging form of lung cancer. It would also offer hope to patients and their families, who have long been in need of more effective treatment options.
Janssen’s submission to the FDA is an important step towards addressing the unmet medical needs of patients with EGFR exon 20 insertion mutation-positive NSCLC. The company remains committed to advancing innovative therapies that can make a meaningful difference in the lives of patients with cancer.
In conclusion, Janssen’s application seeking FDA approval for RYBREVANT® in combination with chemotherapy as a first-line treatment for EGFR exon 20 insertion mutation-positive NSCLC represents a significant milestone in the field of lung cancer treatment. If approved, this therapy has the potential to improve outcomes and provide much-needed hope for patients with this specific mutation.
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- Source: Plato Data Intelligence.
- Source Link: https://platohealth.ai/janssen-submits-supplemental-biologics-license-application-to-the-u-s-food-and-drug-administration-seeking-approval-of-rybrevant-amivantamab-vmjw-in-combination-with-chemotherapy-for-the-firs/
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