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.
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