Licensing new drug Tucatinib (TUKYSA), from HER2CLIMB trial

Hi all,

Please does anyone know anything about this new drug for secondary BC Her2+ patients?
It’s added to Capecitabine and herceptin, and apparently showed good results. The trial has included some UK hospitals (including Mount Vernon, Middx) and it was reported in the New England medical Journal last December. It’s already been licensed in the US, Australia, and Switzerland this summer and is currently going through the European Drug Agency for approval. Unfortunately Brexit will probably cause delays

My onc feels it would be my next best step as Kadcyla is starting to fail after four years of stability, but I don’t know if I can wait as I have no idea of the timescales Involved. It will have to get through NICE too! 
So what I want to know is, does anyone have any experience of this, or has anyone been recommended this treatment recently, or can anyone point me towards sources of information about the European Drug Agency’s processes, and especially how Brexit will affect licensing?

I have two weeks until I talk to him again and may have to accept a less promising drug combination…

Many thanks for any info

Jx

Hi Jacksy

Good to hear from you, but not the circumstances.

I think we are a similar number of lines down the treatment path as we’ve been living with SBC for many years, although we do have different pathology of our BC. I have been in a similar situation recently and my oncologist wrote to all the pharma who manufacture the inhibitor drugs as I’m not eligible to have them through the NHS (I’m too far down the line of treatments). I think he must have mentioned ‘compassionate grounds’ as the basis for his request. Two of the companies responded to say they would fund my treatment themselves thus not involving NICE or the drugs fund. I’m currently on a PI3K inhibitor drug direct from the manufacturer. The costs are enormous if I were to fund it myself (the other CDK inhibitors are not quite so expensive). It too has been licensed in other countries, only last November so is a very new drug and only available on a trial in the UK (which may have finished). It could be worth your oncologist approaching the manufacturer of the new drug to see if they can help?

Wishing  you all the best

Nicky xx

I came across this discussion about Tucatinib (Tukysa) and the HER2CLIMB trial, and it’s definitely a ray of hope for those facing HER2-positive breast cancer. If this drug gets the green light, it could be a game-changer for so many. While navigating clinical trials and new medications can be a rollercoaster, remember there’s support out there.

So, organizations like nationalrehabhotline.org can be a fantastic resource for anyone going through treatment, and can help with managing side effects and figuring out next steps.

Here’s the thing: new drugs are fantastic, but they’re just one piece of the puzzle. Finding the right treatment plan and managing the journey is crucial. I’d love to hear from others about their experiences with HER2-positive breast cancer and what resources helped them weather the storm. Let’s share some knowledge and encouragement in this community!

I’m sorry to hear about your situation. Tucatinib sounds promising, especially considering your oncologist’s recommendation. Waiting for approvals and navigating Brexit uncertainties can be frustrating, I’m sure.