NSCLC: FDA grants full approval for pembrolizumab + chemotherapy


  • Kelli Whitlock Burton
  • Oncology drug update
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Takeaway

  • The FDA has granted full approval to pembrolizumab plus pemetrexed and platinum chemotherapy as frontline treatment for metastatic, nonsquamous NSCLC with no EGFR or ALK mutations.

Why this matters

  • Pembrolizumab received accelerated approval in May 2017, based on findings from the KEYNOTE-021 study that found improved objective response rate and PFS with its addition in patients receiving pemetrexed and carboplatin.

Key facts

  • New, regular approval is based on findings from the KEYNOTE-189 randomized, multicenter, double-blind, active-controlled study of patients with metastatic nonsquamous NSCLC receiving first-line pembrolizumab or placebo with pemetrexed and cisplatin/carboplatin every 3 weeks for 4 cycles, followed by pembrolizumab or placebo with pemetrexed.
  • Pembrolizumab + chemotherapy yielded statistically longer OS (HR, 0.49; 95% CI, 0.38-0.64) and PFS (HR, 0.52; 95% CI, 0.43-0.64).
  • Adverse events reported in ≥20% of patients in KEYNOTE-189 included fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.
  • Recommended pembrolizumab dose and schedule for metastatic nonsquamous NSCLC is 200 mg via intravenous infusion over 30 minutes every 3 weeks.

Prescribing information.

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