Drug Development, EMA

Nektar’s pitch on early cancer drug OK runs into a regulatory brick wall

Nektar Therapeutics’ $NKTR attempt to win an accelerated European OK for its cancer drug Onzeald (NKTR-102) has run straight into a regulatory brick wall.

The CHMP has voted thumbs down on Onzeald, which is also bad news for Daiichi Sankyo, which bet $20 million upfront on a regional licensing pact for the drug.

Nektar and Daiichi Sankyo were gambling on an early OK for this drug after researchers extracted data from their BEACON study on 67 advanced breast cancer patients with a history of brain metastases. That data mining project delivered a 5.2-month overall survival benefit in the drug group compared with a control group who were given a physician’s choice of therapies.

The committee of experts was not impressed:

The CHMP considered that the benefit of Onzeald in the treatment of breast cancer that had spread to the brain had not been sufficiently demonstrated.

The claim of effectiveness relied on data from a subgroup of patients from a main study which, overall, failed to convincingly show the effectiveness of Onzeald. The Committee considered that the data from this subgroup, which were not supported by additional studies, were not sufficient to prove the effectiveness of Onzeald in patients whose breast cancer had spread to the brain, even when analysed by different methods.

Nektar wanted to get the quick European OK as it ran a pivotal study that could keep it on the market in Europe and go on to win entry in the US, but the gambit evidently failed. Nektar now has to wait for the formal EMA decision, but the writing would appear to be on the wall.

Earlier in the week Nektar added new late-stage data on its opioid NKTR-181 which demonstrated that it wasn’t as likeable as oxy, a point that the biotech believes will make it attractive to the big players CEO Howard Robin hopes to strike a deal with. Robin is an aggressive pitcher when it comes to deals. He’ll be even more interested in working a favorable pact now.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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