Erdafitinib – the first targeted drug for advanced bladder cancer was approved

[Joe]

Dr. Peter Black just tweeted that Erdafitinib (sold under the  trade name BALVERSA) had been approved in Canada.

FDA had approved in April, 2019 in US.  FDA Breakthrough Therapy Designation in March 2018.

Erdafitnib is for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and 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.

An analogy is that FGFR is like a cruise control of a car.  When it is working, it controls how fast cells grow. But, when it is broken or the gene is mutated, the cruise control sets higher speed than normal and the cancer cell keeps growing and dividing.   Erdafitinib is supposed to fixed those broken cruise control or inhibit those gene altered FGFRs.

BALVERSA is the product name and it was developed by Johnson Johnson.   In addition, peripheral diagnostic tools have been developed to detect FGFR alternations.

BALVERSA is orally taken.  According to DRUG.com  the price of drug is per US $280 per pill and costs about  US$ 15, 000 for 56 pills.   It is likely to expensive for most of us.

I have a concern about economic burden about this therapy.  It is because it comes in the form of oral pills.  If the therapy requires the patients to be treated at the hospital, it is usually covered by our provincial medical plan. But because it can be sold regular pharmacies, the patients have to pay from their own pocket first and later claim on tax deduction.   It is something to watch out.

Joe

 

 

 

 

 

 

 

• This topic was modified 5 years, 1 month ago by Joe.

[marysue]

Hi Joe:

Thanks for sharing this news.  Do you know how many pills the average treatment regime requires?  This is a great first step but as you say, it may be too great a financial burden for most.

I well remember when I was first going for BCG immunotherapy being terrified of how much it would cost even though my hubby had great health coverage through his work at that time.  Thankfully because it was considered a “standard” treatment here in Alberta and done in a clinic, the cost of BCG was picked up by Alberta Health Services and the Alberta Cancer Board.  As cancer patients, people do not need the extra burden of medical expenses especially if they are off work for treatments and don’t have a full pay cheque coming in.

I hope that the governing bodies of our country will see fit to cover the cost of this treatment.  It shouldn’t matter whether it can be done as an oral treatment or in hospital.

[Joe]

Hi marysue

Below is from FDA, 9 mg once daily and every day till it stops working.  See below.    A company spokesperson said back in April that the price will be about  $18,400 which is comparable to other oncology drugs.  I assume he meant to say $18,400 per month.

Keytruda , immunotherapy sold by Merck costs $100K – $150K per year.   I do not think where can our public healthcare system find the money to pay for it for every patient who may benefit from the drug. I do not know how much if any BC healthcare system is paying to those cancer drug companies, but for now, in British Columbia, BC Cancer Agency has a list of cancer drugs which the drug company basically give free to selected patients.  Keytruda is on the list and so is Trecentric and others.  What concerns me is that we do not know when they will stop such program because almost all drug companies exist to make profit.   Irony is that when drugs are on clinical trials, they are free.   When Health Canada approves it, our healthcare system cannot afford it pay for it.   In case of BC, traditional cancer drugs can be ordered from BC Cancer (BC provincial health service provider) by specifying specific product code. These include BCG, Chemotherapy drugs.  But immunotherapy drugs such as Keytruda and Trecentric  requires a separate approval process – BC Cancer compassionate access program.   I do not know how it is done in other provinces.   Complicated, but the system does exist to access those expensive new drugs.

<span style=”text-decoration: underline;”>Dosage requirement for BALVERSA (erdafitinib)</span>

The recommended starting dose of BALVERSA is 8 mg (two 4 mg tablets) orally once daily, with a
dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO4) levels and
tolerability at 14 to 21 days [see Dosage and Administration (2.3)].
Swallow tablets whole with or without food. If vomiting occurs any time after taking BALVERSA, the
next dose should be taken the next day. Treatment should continue until disease progression or
unacceptable toxicity occurs. 

Joe

 

 

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