Speeds up review process for the pharma company's potential blockbuster
Bayer's regorafenib will have its evaluation process for use in bowel cancer accelerated after receiving priority review status from the US Food and Drug Administration (FDA).
This means that the drug, which Bayer is submitting as a second-line treatment for patients with metastatic colorectal cancer, will have its review completed within six months from receipt of the company's new drug application rather than the standard 10 months.
Priority review is granted by the FDA to medicines that offer either a major advance in care or that provide a treatment where no adequate therapy exists.
Current colorectal cancer treatment options include conventional chemotherapy as well as Roche/Chugai's Avastin (bevacizumab) and Bristol-Myers Squibb/ImClone Systems/Merck Serono's Erbitux (cetuximab), although these therapies often prove ineffective when the cancer reaches an advanced stage.
"We welcome the priority review of regorafenib by the FDA as it supports our efforts to make regorafenib available as early as possible to patients who have exhausted available therapies and urgently need new options," said Dr Kemal Malik, head of global development at Bayer HealthCare.
Regorafenib is a multi-kinase inhibitor that works by blocking the growth of blood vessels in tumours as well as affecting other drivers of cancer growth.
It has demonstrated it can significantly improve both overall survival and progression-free survival, compared to placebo plus best standard care in phase III clinical trials.
The drug is also likely to be submitted for use in the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumours (GIST) having reached its primary endpoint in a separate phase III trial that examined its use in GIST.
Bayer has high expectations for regorafenib, declaring last year it was one of four potential blockbusters in its pipeline that could make over $1bn a year, and the accelerated review process will be welcomed by the German company.
Of the remaining three potential blockbusters, anticoagulant Xarelto (rivaroxaban) has received several approvals in both the EU and US, although was recently turned by the FDA for use in the treatment of patients with acute coronary syndrome.
Meanwhile, Eylea (aflibercept), which was co-developed with Regeneron, has been approved in the US for wet age-related macular degeneration (AMD), and alpharadin has shown positive trial results, demonstrating it is effective at increasing survival in advanced cases of prostate cancer.