Ladies and Gentlemen, we have another DSI "F" up......

EMA panel recommends against Nektar, Daiichi Sankyo's breast cancer drug.......

If we can't get shit through Europe where can we? Time to turn out the lights and get off this ship of fools. Hey walking dead boy when are the next round of layoffs?

 

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.

 

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.

 

It's ok!! We have Movantik/Injectafer/Morphabond to save the day!

 

Let's go to a small - "true specialty" sales force already. Cut the fat and pay the chosen one's a premium to stay. These niche drugs don't warrant the headcount we have in the field. Do it Lisicki.

 

Keller, Lisicki, woolley all the big boys and DMs are just rolling in the $$$ and when it crashes they walk away with millions$$ the Japanese have been hornswoggled (again)!

 

We do work for a Japanese company and decisions are made in Tokyo.

 

DM's walk away with millions? You're dumb.