Amgen’s Kyprolis, J&J’s Darzalex team up on myeloma survival win

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After years of slow growth, Amgen’s Kyprolis finally looks poised to break the blockbuster barrier in 2019, and new data in tandem with the multiple myeloma field’s hottest drug could help boost it even further.

Adding Johnson & Johnson’s Darzalex to a combination of Kyprolis and the steroid dexamethasone cut patients’ risk of disease progression or death by 37% compared with Kyprolis and dexamethasone alone, the Big Biotech said.

Patients treated with the Kyprolis-dexamethasone duo, commonly referred to as Kd, lived a median 15.8 months without their disease worsening, while the median for patients on the cocktail including Darzalex hadn’t yet been reached.

The results pave the way for Kyprolis use alongside Darzalex, a drug that’s seen massive success since its debut as a fourth-line treatment back in late 2015. It racked up $2.03 billion in sales last year after snagging an indication in previously untreated patients—the first ever for a monoclonal antibody.

“The potential to combine KYPROLIS with DARZALEX, two powerful targeted agents, represents an additional therapeutic approach for patients with relapsed or refractory multiple myeloma,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “The results from the CANDOR study confirm the potential for KYPROLIS to be used in combination with an anti-CD38 monoclonal antibody.”

The Kd regimen, meanwhile, has breathed some much-needed life into Kyprolis sales since Amgen added the indication to the drug’s label early last year. Kyprolis—which the company bagged in its 2013 buyout of Onyx Pharmaceuticals—ended 2018 with $968 million in global sales, and it amassed $512 million through the first six months of 2019.

Since its first approval in 2012, approximately 130,000 patients worldwide have received KYPROLIS. KYPROLIS is approved in the U.S. for the following:

  • In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy
  • As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy

KYPROLIS is also approved in Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, Colombia, Ecuador, Egypt, European Union, Hong Kong, India, Israel, Japan, Jordan, Kuwait, Lebanon, Macao, Malaysia, Mexico, Morocco, New Zealand, Oman, Philippines, Qatar, Russia, Saudi Arabia, Singapore, S. Korea, Switzerland, Taiwan, Thailand, Turkey and United Arab Emirates.

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