Erleada

[cfrees1]

What do y’all know about this new drug just approved? I’ve never even heard of it. curetoday.com/articles/fda-...

[ctarleton]

If you search for "apalutamide" or "ARN-509" in the search box on the upper right, or out on the Internet, you will get historical information and conversations during its development leading up to this reported Clinical Trial result.

Charles

[Hidden]

Hi:

Iti is APATULAMIDE, this drug was just approved for non metastatic castration resistant prostate cancer because it offers an advantage to time to metastasis to appear.

"The US Food and Drug Administration (FDA) today approved apalutamide (Erleada, Janssen) for the treatment of patients with nonmetastatic prostate cancer who are at high risk for disease spread because treatment with hormone therapy is not effective and thus their disease is castration resistant.

This is the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer. It is also the first time the FDA used metastasis-free survival (MFS) as the primary endpoint in its decision making.

"In the trial supporting approval, apalutamide had a robust effect on this endpoint. This demonstrates the agency's commitment to using novel endpoints to expedite important therapies to the American public," said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a press statement.

Apalutamide is an orally administered androgen-receptor inhibitor."

mdedge.com/oncologypractice...

[cfrees1]

I was specifically asking my MO about a year ago why all new treatments were for people with metastatic disease. Why not try to prevent/delay the progression to mets? This appears to be an answer to my request. I'm happy for it.

[Darryl Partner]

I wrote a blog article about Erleada this morning. A Patient Community's perspective on Erleada non metastatic catration resistent prostate cancer treatment malecare.org/erleada/

[cfrees1 in reply to Darryl]

You make good points in your blog. Doesn't it follow that if mets are delayed, mortality will be delayed? Or is that too simplistic? I have always believed that once the mets advance to bone or soft tissue, the count down clock starts. Certainly now that it has been approved we should get lots of stories about the drug. I expect I'll continue on bicalutamide until my PSA starts to rise again, and then we'll look at this one.

[Darryl Partner]

So, it sort of makes "sense" that if mets are delayed, than death will be delayed. But, we don't really know. We might learn that the clinical trial plecebo recipients and Erlanda recipients lived out their lives to a similar length, but that the Erlanda recipients had a lower quality of life (because of the impact of the drug/Erlanda). We just don't know yet. It seems likely that Erlanda will extend life, but, it is too early to say that with confidence. I am old enough to remember the Selenium and Vitamin E clinical trial, where almost everyone was confident that patients would either benefit or simply show no issues one way or another. Only that trial had to be stopped early because the mineral and vitamin (sounds harmless) was harming patients.

[cfrees1]

Don't you think there is tremendous value in getting drugs to the approval stage earlier by using time to mets as an endpoint rather than waiting until mortality? This seems to be a great step to me, though I do understand your hesitation because we don't know mortality stats yet. But if these drugs are prolonging life by 2 or 3 years, that only means that we would have to wait 2 - 3 years before approvals.

[Darryl Partner]

I said nothing at all against early approval. Nothing in my comments reflect anything against early approval. Indeed, I've been in this advocacy world for over twenty years and probably have a pretty good reputation as being a powerful advocate for early approval.

I am also an advocate for patients to be fully informed. There are pluses and minuses for all prostate cancer treatments...if we have any hope about being happy no matter what our lives are like during and after treatments, we should be aware and educated consumers.

no worries re whatever misunderstanding you had.