Hormone therapies are well established in breast cancer treatment, working by blocking or reducing levels of hormones that feed tumor growth. If the disease progresses, the next line of therapy includes an injectable drug that specifically targets the estrogen receptor on cancer cells. Several big pharmaceutical companies have been trying to develop drugs that work the same way, but in a more convenient pill formulation. Stemline Therapeutics has beaten all of them to win the first FDA approval of an oral medicine in this drug class.
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Kerryd22
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I think they will go through the motions of a drug trial so you may be offered a place in a trial. I probably won’t be because the hospital clinic I’m at is cash strapped. Any hospital run by Qld Health is but the private hospitals like the Mater don’t seem to have the same problems.
As for drug cost, it’ll be the same old story - the cost of creating it which needs to be recovered. Getting it listed for use by the TGA is only part of the equation. Getting it onto the PBS is what’s really needed but if the oral version isn’t at least the same price as the injection then I fear that its inclusion on PBS is not guaranteed - money is in short supply at the moment with all of us and the government is no exception. That’s the pessimistic outlook though and maybe by some miracle the new drug will be a reasonable cost and the government will be generous and patients will have a choice of SERD drugs. We can only hope 🤗
Lucky if you can get in a clinical trial. Then everything is free. My oncologist said I could go on this one if approved, but FDA in US approved it only for ESR1. Disappointing to see that trials of two other oral SERDs were halted because they were not effective. For now, this is the only one. There are others in trial. One by Zeno pharm is doing well and going into phase 3. We should try to find out what clinical trials of oral SERDs are continuing.
Selective estrogen receptor degraders (SERDs) are a type of hormone therapy used to treat estrogen receptor-positive (ER+) MBC. Oral SERDs are taken by mouth. SERDs attach to and break down the estrogen receptor, which stops or slows cancer cells from growing. Currently, fulvestrant (Faslodex®) is the only SERD approved by the FDA for MBC and can only be given by injection. However, many clinical trials are studying new SERDs, including giredestrant, amcenestrant, and others, that can be given orally.
There’s obviously a lot of energy, time and money being put into SERDs but as usual not every project will be successful as new products need to do better than the existing option.
I was offered places in two trials - one at my own clinic when I was diagnosed de novo and that was the main criteria but for some reason I was deemed ineligible. That turned out to be the Verzenio trial. It’s probably a good thing that I missed out as it was Letrazole and the experimental drug but Letrazole failed for me entirely. Being in a trial would have meant that would have been discovered very quickly but to be fair, it was discovered quickly enough even though I wasn’t in a trial. It was diligence of the registrar when I reported a very minor symptom. I reported it because when the doctor asked me if there was anything else I hesitated and he said ‘if there’s something else you need to tell me because I’m not a mind reader’. So I mentioned a few very small spots on my face that were tingling. He arranged an MRI and discovered that the mets were progressing up my spine and into my skull.
The second was at a different hospital and it required a pik3 response and it meant a six week wait while the tumour was tested in America so I opted not to go there. I checked the other day and it failed as it didn’t produce a better response than the existing option Piqray.
A friend went in a trial which was far from her hometown and found out that her HER+ cancer was now ER+ so she was ineligible for the trial she intended to join but there was another trial being run so she joined that. Sadly she failed on that. I don’t know what it was for right now and my friend tried everything offered but nothing worked. 😢
I admire those like Claire who are willing to put themselves forward for experimental treatments although when I read the morbidity and mortality report for Afinitor I was sorry to find that only about a quarter of participants were prepared to provide the final scans needed to be included in the report. Some people were dead but some had moved and there was no forwarding address and others simply refused to discuss their outcome. That’s the decision they made but the document could have been more accurate and useful if it contained information from a greater number than it did.
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