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NICE approves nivolumab for advanced pre-treated squamous NSCLC

NICE has recommended nivolumab as an option for previously treated squamous non-small cell lung cancer (NSCLC) if the patient has not previously had a PD‑1 or PD‑L1 inhibitor. Treatment must be stopped at two years of uninterrupted treatment, or earlier if the disease progresses.

The decision is based on new data from the CheckMate 017 trial and data collected through its use in the Cancer Drugs Fund (CDF) using the Systemic Anti-Cancer Therapy (SACT) dataset.

While the exact data are confidential, NICE says the hazard ratio using five‑year data from the CheckMate 017 trial showed nivolumab was associated with a statistically significant improvement in overall survival compared with docetaxel.

The new SACT data were collected from 348 people who had nivolumab in the CDF, with a median follow-up of 487 days. The median treatment duration was 3.5 months. NICE concluded that the overall survival estimates using the SACT data were similar to CheckMate 017 data.

NICE said all plausible cost-effectiveness estimates were within what is considered a cost-effective use of NHS resources when the end-of-life criteria were applied. Nivolumab was therefore recommended for use in the NHS as an option for treating locally advanced or metastatic squamous NSCLC in adults after chemotherapy, only if:

  • It is stopped at 2 years of uninterrupted treatment, or earlier if disease progresses; and
  • They have not had a PD‑1 or PD‑L1 inhibitor before.

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