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Wazza222

442 Posts.

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26/01/16

01:34

Post #: 16868568
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Originally posted by Stayso 54 ↑

Came across this. Its probably worth posting because it goes to the heart of what differentiates Novogen from others in the cancer drug development space - in my opinion at least.

Lilly's middling lung cancer drug wins FDA approval with a restrictive label

Eli Lilly ($LLY) won FDA approval for a lung cancer treatment that posted only a marginal survival benefit in late-stage clinical trials, gaining clearance to treat a small population of patients with particularly serious disease.

The antibody therapy, necitumumab, is approved to be dosed alongside two types of chemotherapy for patients with lung cancer that has spread elsewhere in the body. The treatment, to be marketed as Portrazza, is indicated only for patients with squamous non-small cell lung cancer--which accounts for about one-quarter of all lung cancer diagnoses--who haven't received any form of therapy.

Portrazza's limited label is the result of some so-so results in Phase III. A combination of Lilly's treatment and gemcitabine and cisplatin extended patients' lives by just 1.6 months compared with the old chemotherapies alone, and Portrazza's positive effect on progression-free survival amounted to less than a week. The treatment failed to demonstrate any significant benefit in a trial on the more common nonsquamous NSCLC.

Like me, others will no doubt recall the company's former CEO remark along the lines that we will leave the mission to improve outcomes to patients by a few months.

One hopes that the incoming CEO holds the same view. No doubt we will find out at some point soon. No wonder the FDA has approved Novogen submissions/preclinical trials to date with no alterations.

Roll on 2016.

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A nice 24% start on the Nasdaq. Nice Australia Day gift if it continues.

NRT Price at posting: 11.5¢ Sentiment: Buy Disclosure: Held
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