Cyramza® (Ramucirumab)

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Ramucirumab: Lung Cancer

Ramucirumab has been studied for the treatment of patients with NSCLC.

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Indication

The information contained in this letter may not completely match the current local labeling for RAMUCIRUMAB. Please see local labeling approved in your country.

Ramucirumab, in combination with

  • docetaxel, is indicated for the treatment of patients with locally advanced or metastatic NSCLC with disease progression after platinum-based chemotherapy, or
  • erlotinib, is indicated for the first-line treatment of patients with metastatic NSCLC with activating EGFR mutations.1

Phase 3 Studies

REVEL Study

The REVEL study was a randomized, double-blind, placebo-controlled, multicenter, phase 3 study in patients (N=1253) with pathologically confirmed, squamous or nonsquamous, stage IV NSCLC following disease progression during or after 1 prior platinum-based chemotherapy, with or without bevacizumab or maintenance therapy. Patients were randomly assigned to treatment with ramucirumab plus docetaxel or placebo plus docetaxel.2

  • Patients treated with ramucirumab plus docetaxel had a significantly longer median OS compared with patients treated with placebo plus docetaxel (10.5 months vs 9.1 months; HR=0.86; 95% CI: 0.75-0.98; p=.023).2
  • Grade ≥3 TEAEs that occurred in ≥10% of patients in the ramucirumab plus docetaxel arm included neutropenia, febrile neutropenia, leukopenia, and fatigue.2

RELAY Study

The RELAY study was a global, randomized, double-blind, placebo-controlled, multicenter, phase 3 study in patients with previously untreated EGFR mutation-positive, metastatic NSCLC. Patients were randomly assigned to treatment with ramucirumab plus erlotinib or placebo plus erlotinib.3

  • Patients treated with ramucirumab plus erlotinib had a significantly longer median PFS compared with patients treated with placebo plus erlotinib (19.4 months vs 12.4 months; HR=0.59; 95% CI: 0.461-0.760; p<.0001).3
  • Grade ≥3 TEAEs that occurred in ≥10% of patients in the ramucirumab plus erlotinib group included hypertension, dermatitis acneiform, and liver failure/injury.3

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673. http://dx.doi.org/10.1016/S0140-6736(14)60845-X

3Nakagawa K, Garon EB, Seto T, et al. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019;20(12):1655-1669. https://doi.org/10.1016/S1470-2045(19)30634-5

Fecha de la última revisión: 2019 M06 03


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