January 19, 2023
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European regulators have good news for Amgen on cancer drugs


One of the world’s most expensive cancer drugs got conditional approval from European regulators on Sept. 25.

Europeans granted Thousand Oaks-based Amgen conditional approval of its rare blood cancer drug Blincyto and gave a positive evaluation of Amgen’s multiple-myeloma drug Kyprolis.

Blincyto is an immunotherapy that is designed to treat a rare form of leukemia by using a person’s own immune system. Amgen acquired rights to the drug when it bought Maryland biotechnology company Micromet in 2012. The drug costs about $178,000 for two courses of treatment.

In December, the U.S. Food and Drug Administration approved Blincyto to treat acute lymphoblastic leukemia, which has few treatment options once a patient has relapsed.

About 6,250 Americans, mostly children, will be diagnosed with the disease this year and 1,450 will die, according to the American Cancer Society.

The European Medicines Agency conditionally approves a drug when there are few or no treatment options, the disease is considered severely debilitating and when benefits of taking the drug outweigh the risks. Conditional approval is usually granted despite trial data being incomplete. Conditional approvals are renewed annually until trial data is complete. Amgen expects a final decision about Blincyto later this year.

European regulators also gave a positive opinion about Kyprolis, Amgen’s experimental treatment to cure multiple-myeloma. Kyprolis works by preventing the breakdown of proteins in cancer cells, which cause the cancer cells to die. It was the cornerstone of Amgen’s $10.4 billion buyout of Onyx Pharmaceuticals in 2013.

In July, Kyprolis was approved by the FDA to treat patients who had received at least one other treatment for multiple-myeloma. European regulators recommended Kyprolis for the same use on Sept. 25.

The European Medicines Agency still needs to review and finalize decisions about both drugs later this year.

• Contact Philip Joens at pjoens@pacbiztimes.com.