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Homepage – Forum Forums Research, Clinical Trials, and New Treatments FDA warning on immunotherapy and FDA newly approved drug

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    FDA Issued a warning of the use of immunotherapy for certain bladder cancer patients.


    Keytruda and Tecentriq are drugs called PD-1, PD-L2 inhibitors.  PD-1 is the protein found in T-cell and PD-L1 is the protein found in cancer cells. When PD-1 and PD-L1 are bound together. T-cell does not recognize the cancer cell will not kill the cancer cell.  Keytruda is the drug to inhibit PD-1 to prevent the binding of PD-1 and PD-L1.  Tecentriq inhibits PD-L1 to prevent the binding of PD-1 and PD-L1.  The efficacy of Keytruda and Tecentriq are similar.  High PD-L1 expression means there are many PD-L1 proteins on the cancer cell.

    On June 19, 2019 FDA issued the warning as decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).  Because of this warning, it has been reported the decline of immunotherapy drugs and increase in the use of chemotherapies.  In september, this year, Abraham Cancer Center at the University of Pennsylvania had reported that immunotherapy use in first-line decreased from 51.9% prior the warning to 30.0% half a year later.  Platinum-based chemotherapy like Cisplatin or Carboplatin use has increased from 37% to 60.6% during this time.  Maybe, the same trend is happening in Canada but I have not seen any such news. Health Canada had approved both Keytruda by Merck and Tecentriq by Roche a while ago for advanced bladder cancer patients.

    Please note that FDA said that patients taking Keytruda or Tecentriq for other approved uses should continue to take their medication as directed by their health care professional. Also in patients already receiving Keytruda or Tecentriq who are responding to treatment and are cisplatin-ineligible, continuation of treatment could be considered, regardless of PD-L1 status.

    BALVERSA (ERDAFITINIB) by Johnson and Johnson approved by FDA, in May, 2019

    I had  posted about the approval of this drug back in October 27, 2019.  I added simpler explanation.


    The reason why cancer cells grow faster than normal cells is because usually either the genes to control the growth or/and the genes to suppress the growth were mutated and lost its proper function.  Targeted medicine is to attack those mutated genes. BALVERASA will attack genes  which lost its proper function to control the growth.  The genes to control growth are FGFR3 and FGFR2.

    BALVERASA (Erdafitnib) is for the treatment of adults with locally advanced or metastatic bladder cancer patients who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

    It is noted that BALVERASA in the clinical trial showed positive outcome for patients whose PD-1, PD-L1 inhibitors immunotherapy i.e. Keytruda or Tecentriq failed

    I have not seen BALVERASA had approved by Health Canada, yet.


    December 18, 2019

    FDA approves Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate


    Antibody –  it is said that we , an individual, has over billion unique antibodies in our body.   For every foreign invader to our body, the body makes new antibodies to protect our body.  An antibody consists of one pair of heavy chains(each usually containing about 440 amino acids) and a pair of light chains ( each usually containing about 220 amino acids).

    Antibody conjugate drug – It is human engineered antibody with cytotoxic material attached (conjugated) to the antibody.

    Nectin-4 – Nectin-4 is protein which are found many on the surface of bladder cancer cells.

    The company’s website says

    Padcev( enfortumab vedot) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).


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