FDA approves new first-line treatment for NSCLC with specific mutation

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This approval, announced today, transitions the May 2021 accelerated approval of RYBREVANT® to full approval, following the Phase 3 PAPILLON study results.

The PAPILLON study showed a 61 percent reduction in disease progression or death risk when using RYBREVANT® with chemotherapy compared to chemotherapy alone. The National Comprehensive Cancer Network® (NCCN®) has updated its guidelines to recommend this combination as a preferred first-line regimen for the specified patient group.

Lung cancer remains one of the most common cancers worldwide, with NSCLC accounting for the majority of cases. EGFR mutations are prevalent in NSCLC, and patients with the EGFR exon 20 insertion mutation typically have poorer prognoses and limited benefits from existing treatments.

The FDA’s decision is based on the PAPILLON study’s evidence of improved progression-free survival and objective response rate with RYBREVANT® plus chemotherapy. Advocacy groups have welcomed this development, highlighting the potential lifeline it offers to patients and families affected by this type of lung cancer.

The approval of RYBREVANT® plus chemotherapy marks the first targeted approach approved for first-line treatment of NSCLC with this specific EGFR mutation. Johnson & Johnson aims to further advance its lung cancer treatment portfolio based on this milestone.

Despite the optimism surrounding the new treatment, it is important to note the associated risks and adverse reactions. Infusion-related reactions, interstitial lung disease/pneumonitis, dermatologic reactions, and ocular toxicity are among the reported side effects, with specific precautions and recommendations for managing these reactions.

This news article is based on a press release statement, presenting the facts without endorsement of claims. It is important for patients and healthcare providers to discuss all treatment options, including potential risks and benefits, to make informed decisions about lung cancer care.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.