Nexavar approved by European Commission for the treatment of advanced kidney cancer

By E. Janene Geiss

Philadelphia, July 24 - Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. announced Sunday that the European Commission has granted marketing authorization to Nexavar (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Bayer will commercialize Nexavar in Europe, according to a company news release.

The decision by the European Commission to grant marketing authorization to Nexavar followed a positive opinion issued by the European Medicines Agency's Committee on Medicinal Products for Human Use in April.

Nexavar was approved by the Food and Drug Administration in December 2005 and has since been approved in Switzerland, Mexico, Chile, Brazil, Korea and Argentina.

Regulatory filings have been completed in several countries, including Australia, Canada, Turkey and Japan, officials said.

Every year, more than 200,000 people around the world are diagnosed with kidney cancer and more than 102,000 die from the disease.

In Europe, there are more than 46,000 new cases of kidney cancer annually. At the time of diagnosis, the cancer has already metastasized (spread to distant body locations) in about one-third of people with kidney cancer.

The European Medicines Agency's approval of Nexavar was based on phase 3 data from the largest randomized, placebo-controlled trial ever conducted in patients with advanced renal cell carcinoma.

In the phase 3 study, Nexavar doubled progression-free survival in previously treated patients when compared to a placebo, officials said.

In this study, progression-free survival was doubled to a median value of six months in patients receiving Nexavar as compared to three months for patients receiving a placebo.

All subgroups examined, including patients who had not received conventional treatment with biologics, such as interleukin-2 or interferon-alpha, appeared to benefit as well, officials said.

In April 2005, Bayer and Onyx said they discussed the clinical and statistical significance of this analysis with the principal investigators, an independent data monitoring committee and with regulatory authorities and decided that it would not be ethical to continue the study with a placebo-control arm.

The companies immediately recommended that all patients in the trial be offered access to Nexavar.

Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. It is being studied in a variety of cancers; to date, more than 8,000 clinical trial patients have received the drug.

Nexavar is in phase 3 clinical trials for liver cancer and skin cancer.

Enrollment in both these trials has been completed. A phase 3 clinical trial in non-small cell lung cancer for first-line patients was begun in February. In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators.

Nexavar is being co-developed by Bayer and Onyx. The co-development collaboration calls for Onyx to fund 50% of the development and marketing costs for Nexavar worldwide, except in Japan.

In return, Onyx has a 50/50 profit share in the United States, where the companies co-promote the product.

In all other countries (except Japan) Bayer has exclusive marketing rights and Onyx's profit share is slightly less than 50%. In Japan, Bayer will fund product development and Onyx will receive a royalty.

Onyx is an Emeryville, Calif., pharmaceutical company focused on cancer therapies that target the molecular basis of cancer.

Bayer Pharmaceuticals is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Leverkusen, Germany-based Bayer AG.

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