Lilly (LLY) Announces CHMP Issues Positive Opinion to Expand CYRAMZA Label to Include Results from RELAY Study in Patients with Metastatic EGFR-Mutated NSCLC

Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a new indication and associated label update for CYRAMZA® (ramucirumab). The Committee agreed that the label should include an indication for CYRAMZA in combination with erlotinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union.

The CHMP opinion is based on the efficacy and safety demonstrated in the Phase 3 RELAY trial – a global randomized, double-blind, placebo-controlled trial evaluating CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic NSCLC whose tumors have activating EGFR mutations. CYRAMZA, in combination with erlotinib, significantly improved progression-free survival, or the time patients lived without their disease getting worse, in previously untreated NSCLC with activating EGFR mutations. RELAY is the second positive Phase 3 trial of CYRAMZA in NSCLC. The first was REVEL, which supported the approval of CYRAMZA plus docetaxel as a treatment for people with metastatic NSCLC whose cancer has progressed after prior platinum-based chemotherapy.

"There is no cure for people with metastatic EGFR-mutated lung cancer and, despite recent advancements, there remains an unmet need for additional first-line therapeutic options and new treatment strategies," said Anne White, president of Lilly Oncology. "We are pleased with this opinion that recognizes the relevance of the RELAY data, which demonstrate the benefit of combining inhibition of the EGFR and VEGFR2 pathways to treat this type of cancer. Today marks an important step toward making this treatment regimen available for metastatic non-small cell lung cancer patients with an EGFR mutation, and further demonstrates Lilly's commitment to people living with lung cancer."

In addition to the EU, Lilly has made submissions based on the RELAY data in the U.S. and Japan, with regulatory action expected in the first half and second half of 2020, respectively.

The safety profile observed in the RELAY study was consistent with what has been previously observed for CYRAMZA in Phase 3 clinical trials and the established safety profile of erlotinib. The most common (>5% incidence) Grade ≥3 adverse events occurring at a higher rate (≥5% difference) on the CYRAMZA-plus-erlotinib arm compared to the placebo-plus-erlotinib arm were hypertension, dermatitis acneiform (an acne-like rash), and diarrhea.

There is no cure for people with metastatic EGFR-mutated lung cancer and disease progression following acquired resistance remains a challenge. Most patients receive several lines of treatment and the therapeutic regimen prescribed for first-line treatment can impact a person's options for later lines of treatment. EGFR-targeting tyrosine kinase inhibitors (TKIs) are the current standard treatment options for EGFR-mutated NSCLC. Erlotinib, the TKI included in the RELAY trial regimen, is a globally approved treatment option for this type of lung cancer.

Information on previously approved EU CYRAMZA indications can be found here.

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