[Ip-health] FDA approves ivosidenib/Tibsovo, a $870 per day leukemia drug from Agios

James Love james.love at keionline.org
Mon Jul 23 09:03:57 PDT 2018


Sorry about the bad formatting in 1st message.


----------------
This is a Stat article about a $870 PER DAY drug for  Acute Myeloid
Leukemia.   The average duration of therapy is four months, according to
the article but for some patients, apparently longer, since that is an
average.  The drug targets an  IDH1 mutation.

The FDA press release said that just 174 patients were the single arm trial
used to evaluate the efficacy of the treatment. That would make the trial
costs pretty small.  Stat puts the US patient population at 700 to 1,100
persons, based upon the initial label.    If a 1,000 patents received the
drug and paid $100,000 per treatment on average, that would be $100
million, per year, I assume, from the US market, for this indication.

ClinicalTrials.Gov actually lists six trials for the drug,  Five have start
dates, including 3 in 2017 and 2 in 2018.    So this was a pretty quick
turn around.

Only two the of trails are listed as finished.  One Trial has a start date
of July 31, 208, which is next week, and 2 of the trials are still
recruiting.

The company Agios Pharmaceuticals, received 2 NIH grants  "to screen for
chemical inhibitors that are specific for the mutant form of isocitrate
dehydrogenase 1 (IDH1)".  The FDA Orange Book does not yet have a listing
for the drugs or the patents asserted.

https://www.statnews.com/2018/07/20/fda-approves-agios-first-in-class-leukemia-treatment/

The drug, ivosidenib [Brand name Tibsovo]— developed by Cambridge-based
Agios Pharmaceuticals— is a once-daily pill that might replace chemotherapy
for some people with refractory or relapsing AML, a type of blood cancer
that forms in the bone marrow.


https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614115.htm

The efficacy of Tibsovo was studied in a single-arm trial of 174 adult
patients with relapsed or refractory AML with an IDH1 mutation. The trial
measured the percentage of patients with no evidence of disease and full
recovery of blood counts after treatment (complete remission or CR), as
well as patients with no evidence of disease and partial recovery of blood
counts after treatment (complete remission with partial hematologic
recovery or CRh). With a median follow-up of 8.3 months, 32.8 percent of
patients experienced a CR orCRh that lasted a median 8.2 months. Of the 110
patients who required transfusions of blood or platelets due to AML at the
start of the study, 37 percent went at least 56 days without requiring a
transfusion after treatment with Tibsovo.




On Mon, Jul 23, 2018 at 11:59 AM, James Love <james.love at keionline.org>
wrote:

> This is a ​Stat article about a ​
> $870 PER
> ​ DAY​
> ​drug for  Acute Myeloid Leukemia
> .   The average duration of therapy is four month
> ​s​
> , according to the article but for some patients,
> ​apparently ​
> longer
> ​, since that is an average​
> .
> ​ The drug targets an
>>  IDH1 mutation. ​
>
>
> ​The FDA press release said that just
> 174 patient
> ​s were the single arm trial used to evaluate the efficacy of the
> treatment. That would make the trial costs pretty small.  Stat puts the US
> patient population at 700 to 1,100 persons, based upon the initial label.
>   If a 1,000 patents received the drug and paid $100,000 per treatment on
> average, that would be $100 million, per year, I assume, from the US
> market, for this indication.
>
> ​ClinicalTrials.Gov actually lists six trials for the drug,  Five have
> start dates, including 3 in 2017 and 2 in 2018.
> So this was a pretty quick turn around.
>
>
> Only two the of trails are listed as finished.  One Trial has a start date
> of July 31, 208, which is next week, and 2 of the trials are still
> recruiting.
>
> The company Agios Pharmaceuticals, received 2 NIH grants  "t
> o screen for chemical inhibitors that are specific for the mutant form of
> isocitrate dehydrogenase 1 (IDH1)".
> ​  The FDA Orange Book does not yet have a listing for the drugs or the
> patents asserted. ​
>
> https://www.statnews.com/2018/07/20/fda-approves-agios-first
> -in-class-leukemia-treatment/
>
> The drug, ivosidenib
> ​[Brand name Tibsovo]​
> — developed by Cambridge-based Agios Pharmaceuticals— is a once-daily pill
> that might replace chemotherapy for some people with refractory or
> relapsing AML, a type of blood cancer that forms in the bone marrow.
>
>
> https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614115.htm
>
> The efficacy of Tibsovo was studied in a single-arm trial of 174 adult
> patients with relapsed or refractory AML with an
> ​​
> IDH1 mutation. The trial measured the percentage of patients with no
> evidence of disease and full recovery of blood counts after treatment
> (complete remission or CR), as well as patients with no evidence of disease
> and partial recovery of blood counts after treatment (complete remission
> with partial hematologic recovery or CRh). With a median follow-up of 8.3
> months, 32.8 percent of patients experienced a CR orCRh that lasted a
> median 8.2 months. Of the 110 patients who required transfusions of blood
> or platelets due to AML at the start of the study, 37 percent went at least
> 56 days without requiring a transfusion after treatment with Tibsovo.
>
>
>
>
>
>
>


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love


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