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Unanimous FDA panel backing for Onyx’ cancer drug Kyprolis

Final decision expected by end of July for drug’s use in multiple myeloma

Onyx Pharmaceuticals has received unanimous backing from a US Food and Drug Administration (FDA) panel for the use of its drug Kyprolis in advanced blood cancer.

The committee to advise the US drug agency voted 11 to 0 in favour of approving Kyprolis (carfilzomib) to treat patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including both a proteasome inhibitor, such as Takeda/Millennium's Velcade, and an immunomodulatory agent (IMiD).

Although the FDA doesn't have to follow the committee's opinion, the strong vote makes it likely Kyprolis will be approved for marketing in the US, with a final decision to be made by July 27, 2012.

“Today's ODAC recommendation is an important regulatory milestone in the review of Kyprolis for relapsed and refractory multiple myeloma,” said Dr Ted Love, executive VP, research and development and technical operations at Onyx.

The company bought the rights to Kyprolis when it acquired Proteolix for an upfront fee of $276m in October, 2009.

This price will have risen since, however, due to the drug passing certain milestones in its development, including a fast-track designation from the FDA in 2011.

This designation is reserved for drugs that have the potential to treat serious diseases and fill unmet medical needs.

It's likely Onyx would more than make its money back if the drug receives approval, with forecasts from Thomson Reuters predicting the global multiple myeloma market to reach $5.4bn by 2016. These analysts also said that Kyprolis is expected to make $570m in the US alone if approved.

A marketing application is still to be sent to the European Medicines Agency, with the drug currently in phase III trials to help back approval in Europe.

According to Onyx, multiple myeloma is the second most common haematologic cancer and currently affects more than 50,000 people in the US.

It is a cancer of plasma cells – a type of white blood cell in a person's bone marrow – that can lead to tumour growth in bones.

Survival rates from time of first treatment vary from two to six years depending on what stage the cancer is at, according to the American Cancer Society.

Further treatments available other than proteasome inhibitors and immunomodulatory agents include radiation therapy and transplant.

21st June 2012


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