Chasing rivals, Bayer files Nubeqa for new prostate cancer

[Scout4answers]

Perhaps this gives us another alternative when one of the others fail.

Chasing rivals, Bayer files Nubeqa for new prostate cancer use.

March 10, 2022

Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson, and fulfil its aim of €3 billion in peak sales for the drug.

Nubeqa is already making headway in the market as a treatment for non-metastatic, castration resistant prostate cancer (nmCRPC), with sales of €219 million last year, but will need to expand into new forms of the disease if it is to meet its commercial objectives.

Part of that will be to include patients with metastatic, hormone-sensitive prostate cancer (mHSPC) on the label, a group with more advanced disease that is already treated with blockbuster oral androgen receptor inhibitors like Pfizer/Astellas Xtandi (enzalutamide) and J&J’s Erleada (apalutamide).

The latest filings for Nubeqa in the US and Europe are based on the ARASENS trial which showed that adding the drug to androgen deprivation therapy (ADT) and docetaxel chemo led to a statistically significant improvement in overall survival (OS) compared to ADT plus docetaxel and placebo.

The risk of death was significantly lower – by around 33% – in the Nubeqa group compared to the placebo group, according to the results, which were published in the New England Journal of Medicine in February.

There was also a big increase in the duration of response, from a media of just under 17 months to 41 months.

Around 95% of prostate cancers are localised at diagnosis and treated with surgery or radiotherapy, but tend to relapse. When this happens, the first line of drug treatment for hormone-sensitive tumours is ADT, with chemotherapy layered on top if needed. Most men with metastatic CSPC will eventually progress to CRPC, which has poor survival prospects.

“For men with mHSPC, there remains a high need for new treatment options that can extend overall survival and delay the progression to CRPC,” said Christine Roth, Bayer’s head of oncology.

Bayer and its development partner for Nubeqa – Finland’s Orion Pharma – reckon that their drug may have a safety advantage that will help it wrest market share from Xtandi and Erleada, and the ARASENS data has prompted them to triple their peal sales forecast for the drug from €1 to €3 billion.

Some analysts think however that may be a tough given that the efficacy of the drugs are comparable, and physicians have more experience with the Pfizer/Astellas and J&J therapies.

[6357axbz]

What do you write, “Phil TaylorPhil Taylor” at the beginning of your post?

[Scout4answers in reply to 6357axbz]

He is author of article

[6357axbz in reply to Scout4answers]

TY

[Pianodude]

I just added Nubeqa to my Orgovyx treatment. So far other than being more tired than usual, I am getting very few side effects.

[GeorgeGlass in reply to Pianodude]

Are you in the U.S.? Is insurance covering it? Are you castration sensitive or resistant?

[Pianodude in reply to GeorgeGlass]

I am in the US. Insurance turned me down. Waiting to hear from Bayer to see if they will give me a break moving forward. I am castrate sensitive.

[GeorgeGlass in reply to Pianodude]

Please let me know what they say. I think my doctor is going to tell me he can't prescribe it to me at next week's appt. I think he's going to recommend Xtandi instead. See if your doctor will pursue "Right to Try" protocols. I'm going to try that if I need to. Someone on this site was able to get it that way.