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Bayer files colorectal cancer drug regorafenib in EU, US

Drug tipped to reach blockbuster status if approved

Bayer research centre in Berlin, Germany

Bayer has filed for approval in both the EU and US for regorafenib, a candidate treatment for metastatic colorectal cancer developed in collaboration with Onyx Pharmaceuticals.

Regorafenib is one of four drugs in Bayer's late-stage pipeline tipped as having blockbuster (€1bn-plus) sales potential, and works as a multi-kinase inhibitor, blocking the growth of blood vessels in tumours as well as affecting other drivers of cancer growth.

The applications are based on the results of the phase III CORRECT trial, which found that regorafenib significantly improved both overall survival and progression-free survival compared to placebo when administered on top of best supportive care.

Patients enrolled in the study had advanced, metastatic colorectal cancer that had progressed despite prior treatment with standard regimens for the disease, which along with conventional chemotherapy include Roche/Chugai's Avastin (bevacizumab) and Bristol-Myers Squibb/ImClone Systems/Merck Serono's Erbitux (cetuximab).

Like Bayer and Onyx' already-marketed cancer drug Nexavar (sorafenib), regorafenib blocks VEGF receptors, a molecular mechanism already targeted by a number of recently introduced cancer drugs including Pfizer's Sutent (sunitinib) and Inlyta (axitinib) and GlaxoSmithKline's Votrient (pazopanib).

Analysts have suggested that regorafenib's ultimate sales potential will depend on how well Bayer can position it against its competition in combination with established chemotherapy regimens for colorectal cancer.

Other competitors in the colorectal cancer segment are likely to come from Regeneron/Sanofi's Zaltrap (aflibercept) - due to be filed in the summer - and ImClone Systems/Eli Lilly's ramucirumab which is in phase III development.

Meanwhile, regorafenib has also shown promising results in gastrointestinal stromal cancers (GIST), and the company said earlier this year it also intends to file for approval in this indication. Various follow-up cancer indications have reached the phase II testing stage.

"These submissions of regorafenib for metastatic colorectal cancer are … a step forward in bringing a potential new treatment to patients with metastatic colorectal cancer who currently have no other options," said Kemal Malik, Bayer's head of global development.

24th May 2012

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