Lilly is celebrating the approval by the US FDA of Cyramza, a new drug for stomach cancer that is considered one of the brightest candidates in its near-term pipeline.
Cyramza (ramucirumab) has been cleared to treat patients with a form of stomach cancer known as gastroesophageal junction adenocarcinoma that cannot be surgically removed or has spread after treatment with other drugs.
The drug has been tipped by some analysts to become a $1bn-plus product if it also wins approval in other indications – including liver, colorectal and non-small cell lung cancer (NSCLC) – although it disappointed in a phase III trial in breast cancer.
Ramucirumab is a VEGF receptor 2 inhibitor which is designed to block blood vessel growth in tumours, and has been shown in the phase III REGARD trial to boost median overall survival to 5.2 months, compared to 3.8 months for placebo. It is also in a phase III trial called RAINBOW, which is looking at its role in combination with paclitaxel as a second-line therapy for advanced gastric cancer.
“Although the rates of stomach cancer in the US have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research (CDER).
“Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumour growth,” he added.
Ramucirumab is one of two late-stage cancer drugs in Lilly’s pipeline, the other being necitumumab which has already generated positive results in a phase III trial involving patients with squamous NSCLC. Both ramucirumab and necitumumab were acquired by Lilly when it took over ImClone Systems in 2008 for $6.5bn.
The cancer portfolio is a bright spot for Lilly, which has been plagued by a series of late-stage pipeline failures in the last couple of years, including edivoxetine for depression, schizophrenia candidate pomaglumetad methionil and Alzheimer’s candidate solanezumab, although the latter remains in clinical testing as an early-stage therapy.