MHRA approves J&J's Lazcluze/Rybrevant combo for lung cancer

Johnson & Johnson’s (J&J) Lazcluze (lazertinib) has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) as part of a combination therapy for a specific group of lung cancer patients. This new treatment approach involves using Lazcluze alongside J&J’s existing cancer medication Rybrevant (amivantamab) to address non-small cell lung cancer (NSCLC) that has metastasized and exhibits certain modifications in the epidermal growth factor receptor (EGFR) gene.

In the United Kingdom, lung cancer is a significant health issue, with approximately 47,000 new cases diagnosed annually. NSCLC is the predominant type, representing up to 85% of all lung cancer cases. Among these, mutations in the EGFR gene are particularly frequent, especially in individuals with lung adenocarcinoma.

Lazcluze, administered daily in tablet form, functions by inhibiting the EGFR, potentially slowing or halting the progression of lung cancer and reducing tumor size. The MHRA’s approval was largely influenced by promising outcomes from the extensive MARIPOSA clinical trial. This study evaluated the effectiveness of Rybrevant combined with Lazcluze compared to the current first-line treatment, AstraZeneca’s Tagrisso (osimertinib), for the same patient group.

The trial successfully reached its primary endpoint, with the combination of J&J’s drugs showing a 30% decrease in the risk of disease progression or death compared to Tagrisso over a median follow-up period of 22 months. Furthermore, the median duration of response was superior for those treated with Rybrevant and Lazcluze, extending to 25.8 months versus 16.8 months for those on Tagrisso. The safety profile for the combination therapy remained consistent with earlier findings from phase 1 and 2 studies.

Julian Beach, the interim executive director of healthcare quality and access at the MHRA, expressed confidence in the approval, emphasizing that patient safety is paramount. He stated, “We are pleased to confirm the approval of Lazcluze for treating adults with NSCLC. The regulatory standards for safety, quality, and effectiveness have been thoroughly met. As with all medical products, we will maintain vigilant oversight of its safety.”

This approval by the MHRA follows a similar endorsement by the European Commission, which authorized the Lazcluze and Rybrevant combination for treating EGFR-mutated NSCLC a little over two months prior. Henar Hevia, senior director and EMEA therapeutic area lead for oncology at J&J Innovative Medicine, highlighted the significance of this approval, noting that it represents notable progress for individuals affected by the severe implications of EGFR-mutated NSCLC, a condition often associated with a grim prognosis and limited treatment choices.

The recent regulatory approvals for the Lazcluze and Rybrevant combination provide a new therapeutic option for NSCLC patients, offering hope for improved outcomes in a landscape where effective treatments have been scarce. This development underscores the ongoing efforts to advance cancer treatment and enhance the quality of life for those battling this challenging disease.