Wednesday, November 25, 2015

Nivo/Opdivo approved as first line for melanoma!

Nivolumab/Opdivo (the drug I took in my trial) has gained FDA approval for use as a single agent, front line treatment for BRAF V600 wild type, unresectable or metastatic melanoma according to announcements put out today! FDA approves frontline opdivo for advanced melanoma
And here: FDA Approval of Opdivo in BRAF V600 WT Melanoma

Have to say, I don't like the limitation based on BRAF status...since we already know that such status doesn't matter in terms of a response to anti-PD1:  Nivo/Opdivo effective no matter BRAF status
The restriction in today's announcement is based on the way the data was attained from the study used to gain this approval, the CheckMate 066 trial.  (The narrow way in which trials are used when drug companies gain approval from the FDA is a HUGE problem.  Human brains are not so narrow as to only be able to interpret data in specific, grouped sets! We really are capable of putting two and two together and while Opdivo proved effective in the wild type ratties in the 066 study, we have simultaneously learned that other ratties respond as well.  Tunnel vision is NOT required!) But, this approval gives one more option for lots of melanoma peeps and as more and more Opdivo approvals are gained, the more latitude docs will have in the way they prescribe it.

Here's some more ways Opdivo has been approved and is helping others:
  • Advanced renal cell carcinoma (11/23/2015)
  • Advanced non-squamous non-small cell lung cancer - after platinum based chemo (10/9/2015)
  • In the Nivo/Opdivo with Ipililmumab/Yervoy combo for BRAF V600 advanced melanoma (10/1/2015)
  • Advanced non-small cell lung cancer - after platinum based chemo (3/4/2015)
  • For melanoma, after failing ipi, and if BRAF positive, BRAFi (12/22/14) 
Additionally, Nivo/Opdivo has shown high response rates (87%) for relapsed or refractory Hodgkin Lymphoma.  Studies are currently looking at Opdvo combined with the anti-CD27 antibody, Varlilumab as well as Opivo/Yervoy combined with GM CSF (sargramostim) for melanoma.

NOW!  Let's see Opdivo approved for BRAF positive folks....FIRST line!!!  We've got ipi, a more toxic, less effective drug in melanoma...though a huge boon for folks who need it...approved for NED melanoma folks.  Let's get Nivo/Opdivo approved for the NED melanoma patients.  My ratties have proven its worth!!  Tunnel vision with FDA approvals is silly, non-nonsensical, and patients with deadly illnesses die while bureaucrats fail to put 2 and 2 together!!

Hang in there, ratties!  Slowly but surely, you are changing the world! love, c

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