Former Nebraska Sen. Ben Sasse was told he had months to live after he was diagnosed with pancreatic cancer in December. Sasse credits "providence, prayer, and a miracle drug" with extending his life.
Watch Sasse's interview with Scott Pelley, Sunday on 60 Minutes.
If #FDA approved IL15 for treatment of lymphopenia due to 1 condition, then it’s reasonable to use it for lymphopenia in all conditions. One drug for one disease. #epogen for anemia regardless due to chemo, infection or kidney issues. If expanded access, it’s approvable for all.
$ibrx IL15 is a natural product of human body and its use to correct lymphopenia is physiological. Many studies showed lymphopenia is associated with short survival of cancer. It’s reasonable to correct treatment induced lymphopenia without need to show it will prolong survival.
$ibrx just like chemo induced leukopenia and #Neulasta. No need to show Neulasta actually prevent sepsis/severe bacterial infection because of #leukopenia. Similarly no need to show #epogen prolongs survival of anemic patients due to #hypoxia. This is the other side of argument.
@bluefinsashimi@DrPatrick I don’t get this. $ibrx why would you think picking a fight with #FDA is a winning strategy? Is FDA really wrong requiring data?
@James5225118482@DrPatrick There is a good chance that $ibrx can do this like $rvmd. It needs to do good trials and gets good data. A lot patients waiting for something like this.
@yachmod @US_FDA My guess is #FDA will not cave in, & $ibrx will need to do trials for treatment induced lymphopenia in a lot of cancer types, which $ibrx is not doing. Moving to other indications will not resolve this issue. Giving cultured NK cells is entirely different way and needs more data
$ibrx the value is to treat lymphopenia associated with cancer treatment. There are large data sets showing lymphopenia is associated with shorted survival in various cancers. #FDA wants data to show correcting lymphopenia can prolong survival. NMIPBC is just a rounding error.
@yachmod @US_FDA There are two sides. The drug is modified natural product with known effects. $ibrx believes its use to correct lymphopenia in all patients is important, similar to epogen in anemia and neupogen in leukopenia. However, #FDA wants to see data on correctin lymphopenia is beneficial
A lot patients with cancer related lymphopenia will benefit from the drug, but the drug is narrowly approved and most patients won’t be able to get it. That’s really the most important issue. $ibrx should address this. To go after other big indications requires more resources.
$ibrx There is only one current trial for expanded access for lymphopenia. It seems $ibrx thinks FDA is wrong on requiring more data in treatment related lymphopenia in all other cancer types, and $ibrx is not willing to provide the data. It’s an interesting, & unique scenario.
@ALulko #sepsis & #community acquired pneumonia are large indications and it will take time to generate data. $ibrx may believe all those data already sufficient for #FDA approval in cancer treatment induced lymphopenia.
@ALulko This trial is a bit different from the lymphopenia associated with cancer treatment, because the patients with bladder cancer may not have lymphopenia. This is a direct cancer cell killing trial. $ibrx the low hanging fruit seems to be the lymphopenia induced by cancer therapy.
To do #RCT on every cancer to treat the same lymphopenia is probably unnecessary. What data to obtain depends on discussion with #FDA. $ibrx already has a lot of data on various cancers. When #lung cancer data published, it will add weight to discussion.