7 replies to this topic

[GerryL]

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of SYNRIBO^® (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.

SYNRIBO is indicated for adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).

http://www.news-medi...-injection.aspxhttp://www.news-medi...-injection.aspx

[hannibellemo]

I know nothing about this drug, but when I read your post the first thing that came to mind is that, as an injectable, it would most likely be covered under major medical like most other non-oral cancer treatments. That could be a plus for many with high deductibles and no or high out of pocket for their drug plans. Of course, I have no idea how effective it is or how it works.

Sad isn't it, how it all comes down to insurance?

Pat

[Marnie]

A year or so ago, I got a call from the marketing company who had been hired by the pharma producing this.  They were doing marketing research.  It was very interesting to talk to them and do their marketing surveys.  It was also interesting to know that this was one more thing in the pipeline. 

[Trey]

Chemo.  The only usefulness is if all else fails and you need something to keep you going for a little while longer. 

[Tedsey]

I know.  When I saw "omacetaxine" that was the first thing I thought.  The other flash thought was how horrible it would make a person feel.

I seem to question if this could be added to the pipeline.

[Marnie]

Obviously I don't know my chemo meds.  What is the clue that it's chemo? 

[Trey]

A clue is the drug name ending  "ine" which many chemo names use.  This is a pine tree sap derivative which has been used by the Chinese for a couple thousand years.  It is not targeted toward leukemic cells, so it kills multiple types of cells, both good and bad.  That is what makes it chemo.  Not much better than Hydroxyurea.  The Synribo website says "a detailed understanding of how SYNRIBO works has not been fully defined", so they don't even really know hows it works.  The clinical trial results were not very impressive.  But it is not completely useless, since It can help those who fail all TKIs and cannot tolerate a bone marrow transplant.  But its effects are short term and the injections are twice a day for 14 days every month.  No thanks.

http://www.cancer.go...nemepesuccinate

[Marnie]

  The marketing survey research was very interesting.  In all of the pamphlets they showed me, there was very little information on how it works, which I found to be strange.  Their data was also very vague, which I questioned, but of course, the firm they hired for marketing was only interested in the marketing aspect of the product.  I think it will be worth watching to see how this new "treatment" will be viewed by oncologists, and if it will be considered an additional option or if it will only be used if others are ineffective.  That's not how they were intending to market it. . .at least not by what I saw.

m