Are there any new colon cancer drugs actually ready for FDA approval?

Hatshepsut
Hatshepsut Member Posts: 336 Member
edited March 2014 in Colorectal Cancer #1
I keep reading that there are all these promising colon cancer drugs "in the pipeline." I confess that I find that very hopeful.

My husband's recent diagnosis of a serious recurrence and the oncologist's statement that the chemotherapy mixture of oxaliplatin, vectribix, and xeloda represents the last drugs he (the oncologist) has in his arsenal to treat my husband's disease caught me off guard, however. I had thought that we had other options.

We have committed ourselves to follow the tough chemotherapy regimen our oncologist has recommended (along with complementary nutritional support) and we are optimistic that it will work. But, in life, you always need to have a "Plan B" to cover a situation if what you expect to work doesn't.

Bottom line, does anyone know if there are any new drugs even close to FDA approval?

Hatshepsut

Comments

  • ADKer
    ADKer Member Posts: 147
    #2
    Perifosine
    Here is a thread at the Colon Club about a new drug which has been "fast-tracked" for FDA approval: http://coloncancersupport.colonclub.com/viewtopic.php?f=1&t=12555&sid=80ec4d2efe08eae3707360b4483c39e1

    I keep notes about information that I find concerning drugs in development. Somewhere I found the following about perifosine: "At ASCO in June 2009 a study was presented showing potential benefit of a novel inhibitor of AKT and MAPK in patients with metastatic colon cancer in second and third line chemotherapy. An update at the 2010 ASCO GI meeting in January further confirmed these promising results.This was a randomized phase II study comparing Xeloda alone versus a combination of Perifosine and Xeloda.The target of this novel inhibitor are AKT and MAPK and JNK pathways, which are frequently altered in patients with metastatic colon cancer. When AKT is mutated or highly active, colon cancer cells grow and spread more aggressively and are more resistant to chemotherapy.
    Perifosine is the first inhibitor of AKT which shows very promising clinical benefit. The time to tumor progression doubled for patients who received perifosine and Xeloda compared to patients who received only Xeloda. The Keryx Biopharmaceuticals, the company manufacturing Perifosine, is planning a registration phase III trial to get this drug approved for the market."

    I believe that someone posted in this forum about success with a clinical trial at Johns Hopkins involving Sorafenib with Erbitux on patients both with and without the KRAS mutation. Also, there are PARP inhibitors such as Olaparib for which there may be clinical trials at Fox Chase in Philadelphia.

    Sorry this isn't more detailed. My notes are not real thorough - just enough to give me something to start with if I want to do more research.
  • coloCan
    coloCan Member Posts: 1,944 Member
    #3
    ADKer said:

    Perifosine
    Here is a thread at the Colon Club about a new drug which has been "fast-tracked" for FDA approval: http://coloncancersupport.colonclub.com/viewtopic.php?f=1&t=12555&sid=80ec4d2efe08eae3707360b4483c39e1

    I keep notes about information that I find concerning drugs in development. Somewhere I found the following about perifosine: "At ASCO in June 2009 a study was presented showing potential benefit of a novel inhibitor of AKT and MAPK in patients with metastatic colon cancer in second and third line chemotherapy. An update at the 2010 ASCO GI meeting in January further confirmed these promising results.This was a randomized phase II study comparing Xeloda alone versus a combination of Perifosine and Xeloda.The target of this novel inhibitor are AKT and MAPK and JNK pathways, which are frequently altered in patients with metastatic colon cancer. When AKT is mutated or highly active, colon cancer cells grow and spread more aggressively and are more resistant to chemotherapy.
    Perifosine is the first inhibitor of AKT which shows very promising clinical benefit. The time to tumor progression doubled for patients who received perifosine and Xeloda compared to patients who received only Xeloda. The Keryx Biopharmaceuticals, the company manufacturing Perifosine, is planning a registration phase III trial to get this drug approved for the market."

    I believe that someone posted in this forum about success with a clinical trial at Johns Hopkins involving Sorafenib with Erbitux on patients both with and without the KRAS mutation. Also, there are PARP inhibitors such as Olaparib for which there may be clinical trials at Fox Chase in Philadelphia.

    Sorry this isn't more detailed. My notes are not real thorough - just enough to give me something to start with if I want to do more research.

    FDA APPROVED DRUGS FOR TREATMENT OF CRC:
    as per ccalliance:5Fluorouracil(5FU)
    Camptosar (Irinotecan/CPT-11
    Xeloda (capecitabine)
    Eloxatin (Oxaliplatin
    Avastin (Bevacizumab)
    Erbitux (Cetuximab)
    Vectibix (Panitumumab)

    Might want to Google something new called Sym004 for advanced solid tumors going into trial as is drug mentioned in prior post, which FDA is fast-tracking now.

    steve
  • Hatshepsut
    Hatshepsut Member Posts: 336 Member
    #4
    Thank you.

    Thank you for the information.

    I needed some good news about potential new drugs.

    One question, though, how fast is "fast tracking" by the FDA?

    Hatshepsut
  • John23
    John23 Member Posts: 2,122 Member
    #5
    Hatshepsut said:

    Thank you.

    Thank you for the information.

    I needed some good news about potential new drugs.

    One question, though, how fast is "fast tracking" by the FDA?

    Hatshepsut

    My "plan B".


    I don't plan to wait for bureaucratic approval.

    http://scri.ngen.com/

    I hope your spouse does well; he's been in my thoughts.


    John
  • ADKer
    ADKer Member Posts: 147
    #6
    Hatshepsut said:

    Thank you.

    Thank you for the information.

    I needed some good news about potential new drugs.

    One question, though, how fast is "fast tracking" by the FDA?

    Hatshepsut

    fast tracking
    I believe that the article indicated that fast tracking meant that the drug might be approved by 2011. I assume that it would also be available through the phase III trial before that time.

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