(Lung Cancer) Ramucirumab Drug Information

Ramucirumab (Cyramza), an anti-angiogenic drug for non-small cell lung cancer, officially approved in Japan

On June 20, Japan's Eli Lilly announced that the anti-angiogenic VEGFR2 antibody Ramucirumab (Cyramza) had received manufacturing and marketing approval for the treatment of unresectable, recurrent non-small cell lung cancer (NSCLC).

The approval was based on multiple study results, including: international multi-center, placebo-controlled, double-blind, randomized Phase III clinical trial (REVEL trial); Japan-specific multi-center, placebo-controlled, double-blind, randomized Phase II clinical trial (JVCG trial); and other supporting evidence.

In the REVEL trial, the study population included patients with NSCLC who were currently receiving or had progressed or relapsed after platinum-based chemotherapy. The trial compared placebo + docetaxel versus Ramucirumab + docetaxel as second-line chemotherapy in patients with progressive or relapsed NSCLC. Results showed improved overall survival with the combination compared to chemotherapy alone.

The JVCG trial enrolled Stage IV NSCLC patients (with or without maintenance therapy) who were receiving or had received first-line platinum-based chemotherapy. The trial was limited to Japanese patients and compared placebo + docetaxel versus Ramucirumab + docetaxel for efficacy. The primary endpoint was progression-free survival (PFS), and secondary endpoints included overall survival and response rate. Results showed consistent trends with the REVEL trial.

Note: Docetaxel is the European taxane (known in Taiwan as Taxotere).

Reference: A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer

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