Please login to the form below

Not currently logged in
Email:
Password:

Onyx gets green light from US FDA for multiple myeloma drug

Accelerated approval comes despite lack of data on overall survival

The US Food and Drug Administration (FDA) has granted Onyx Pharmaceuticals accelerated approval for its multiple myeloma drug Kyprolis, prompting a 12 per cent surge in the company's share price.

The agency cleared Kyprolis (carfilzomib) as a treatment for patients with multiple myeloma whose disease had progressed despite two prior rounds of therapy, including Takeda/Millennium Pharma's Velcade (bortezomib) and an immunomodulatory agent such as thalidomide.

The approval was based on the results of a single-arm phase IIb study which found an overall response rate (ORR) of 22.9 per cent with Kyprolis and a median response duration of 7.8 months.

Currently, no data are available for Kyprolis that demonstrate an improvement in progression-free survival or overall survival, but approval has been given on the basis of the surrogate endpoint because it is "reasonably likely to predict a clinical benefit to patients," said the FDA.

Kyprolis treatment is associated with some significant safety issues, including heart failure, and the approval includes a requirement for close monitoring of patients receiving the drug.

Enrolment for a confirmatory phase III clinical trial called ASPIRE has been completed and this study should provide further insight into Kyprolis' safety and clinical efficacy.

"The approval of Kyprolis provides a treatment option to patients with multiple myeloma whose disease has progressed despite use of available therapies," commented the FDA's Richard Pazdur.

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

Treatment has been transformed in the last decade with several new drugs to treat the disease coming to market, including Velcade and Celgene's Revlimid (lenalidomide) and Thalomid brand of thalidomide.

Thomson Reuters has predicted that the multiple myeloma market could reach $5.4bn by 2016, with Kyprolis contributing sales of more than $550m from the US market alone and up to $1.5bn if it can also secure approval in the EU and other markets.

24th July 2012

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Say Communications

Influencing positive behaviours and delivering change is what drives us, using thought leadership, education, social and professional engagement and compelling,...

Latest intelligence

Is telehealth delivering on its promises?
Using new digital technologies to help patients see their doctors online and not need to attend their surgery can help save time and money - but just how well is...
Channel purpose, change lives
GCI Health's Laura Starr on the power of creativity in health and wellness, all founded upon authentic brand purpose....
Wearables: the tangible product of the patient revolution
As the relationship between the patient and his doctor evolve, we look at how new technology is playing its part...

Infographics