Bayer and Onyx file for EU and US approval for expanded use of Nexavar; completes Steigerwald buy

German drug major Bayer (BAYN: DE) and US partner Onyx Pharmaceuticals (Nasdaq: ONXX) have filed for marketing authorization in Europe and the USA for their oral multi-kinase inhibitor Nexavar (sorafenib) tablets, for the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioactive iodine (RAI), for which there are currently no specifically approved treatments.

“The filings in the USA and Europe for sorafenib for the potential treatment of differentiated thyroid cancer bring us closer to addressing a significant medical need for patients whose disease has advanced and who have limited or no treatment options,” said Kemal Malik, a member of the Bayer HealthCare executive committee and head of global development. “Nexavar is already approved in other indications like hepatocellular carcinoma and advanced renal cell carcinoma. We are committed to fully exploring sorafenib’s applicability across tumor types, especially in hard-to-treat cancers where there are limited treatment options,” he added. In its current indications, Nexavar last year generated sales of 792 million euros ($1.03 billion).

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