Eli Lilly’s Cyramza Passes FDA Advisory Hurdle For NSCLC

Eli Lilly’s Cyramza appears to be on its way to picking up its sixth approval from the U.S. Food and Drug Administration as a treatment for some lung cancer patients following narrow support from an advisory committee.

On Wednesday, Indianapolis-based Eli Lilly announced the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-5 in favor of Cyramza (ramucirumab) plus erlotinib as a potential treatment for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC). The committee said the Cyramza combination demonstrated a favorable benefit/risk profile for, based on the results of the positive Phase III RELAY study. Results from that study showed that treatment with Cyramza in combination with erlotinib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to erlotinib alone. The combination treatment achieved a median PFS of 19.4 months, compared to a 12.4-month improvement over erlotinib alone, the company said in October, when it published the trial results in Lancet Oncology.

Lilly noted that the safety profile in the RELAY study was consistent with what has been previously observed for the drug in other Phase III clinical trials. The most common Grade 3 adverse events that occurred on the Cyramza were hypertension, dermatitis acneiform and diarrhea.

Maura Dickler, vice president of late-phase development at Lilly Oncology, said the company is encouraged the majority of the advisory committee voted in support of the drug’s safety and efficacy profile.

“We believe in the clinical meaningfulness of the data from the RELAY trial, which targeted the VEGFR and EGFR pathways together. We look forward to continuing to work with the FDA on this application to offer a new front-line treatment option for people with metastatic EGFR-mutated non-small cell lung cancer,” Dickler said in a statement.

In the U.S., it is estimated that approximately 15% of people diagnosed with NSCLC have a mutation of EGFR, which is a protein that helps cells grow and divide. When the EGFR gene is mutated it can cause the protein to be overactive, resulting in the formation of cancer cells. EGFR mutations may occur in 10 to 35% of NSCLC tumors globally, the company said. 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 therapy. Globally, tyrosine kinase inhibitors, which includes erlotinib, are the current standard treatment option for EGFR-mutated NSCLC.

Cyramza is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that binds and blocks the activation of VEGF Receptor 2. It has been approved for a number of indications by the FDA, including colorectal cancer, gastric cancer, non-small cell lung cancer and, its most recent regulatory approval, hepatocellular carcinoma. When Cyramza was approved for HCC, the company noted that the FDA removed the boxed warning from the drug’s label. The warning had been in place to mark the possibility of hemorrhage, gastrointestinal perforation and impaired wound healing.

While the advisory committee did support the combination treatment, the FDA is not bound to follow its recommendation. Lilly is seeking approval for the combination treatment outside the U.S. as well. In January, the European Medicines Agency gave the combination the green light and the company is seeking approval in Japan.-Bio Space