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Comment by instagraham | Hacker News Reader

> Tagrisso earned $5.8bn in sales in 2023 — 13 per cent of AstraZeneca’s total oncology sales — making it the company’s highest earner.

The drug seems to have been approved in 2015-16. If that's the case, why is this announcement of efficacy happening now? A long-term outcome after a short-term tentative approval?

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It was approved for certain types of cancers and has slowly been approved for more and more types of cancer, basically.

> Dec 21, 2020 Approval Tagrisso Approved in the US for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Non-Small Cell Lung Cancer

> Apr 18, 2018 Approval FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer

> Jun 6, 2017 AstraZeneca Presents Tagrisso (osimertinib) Data in Patients with EGFR T790M-Mutation Positive Lung Cancer and Central Nervous System Metastases

> Mar 31, 2017 Approval Tagrisso (osimertinib) Receives FDA Full Approval

> Nov 13, 2015 Approval FDA Approves Tagrisso (osimertinib) for EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer

https://www.drugs.com/history/tagrisso.html

US approval follows the path of one treatment for one ailment.

so if something was useful for 100 ailments, it needs 100 different approvals, and a company willing to attempt doing that

what more likely happens is one treatment is denied for the one ailment the company thought they were tackling, and that one treatment is never pursued again

so there's a lot of waste in this particular approach to protecting the public. I'm not familiar with other approaches.

Seems like there's a lot of opportunity with those unused treatments, if you can get the right arrangement of capital. If the company gives up on pursuit, perhaps the'd sell it for less than the R&D cost. Someone could go scoop up 'losers' and find a better way to match them to ailments.

This happens. Drug companies sell off IP and technology quite often.

The bottle neck is you need someone with a better use hypothesis, and a billion dollars to test that. Drug Trials and development are obscenely expensive.

Why doesn't the company pursue it for other purposes? Sounds extremely narrow, as per the comment above. There may be related stuff where it works as a treatment depending on the endpoint?

Because it is extremely expensive and complex to pursue each each use. At some point of diminishing returns, it makes sense to let the medical community lead the process of finding and testing uses.

because there is always lower hanging fruit at that point.

Even if this was the most altruistic, non-profit funded goal to solve an obscure ailment, once that inevitably fails - and statistically it is inevitably - all capital has been expended, your team's reputation has been spent. You go to something that has more consensus instead of your alchemy concoction nobody's ever head of and wasn't good for the one thing you made it for.

One other facet to consider is that it is already legal to for doctors to the medicine for any of those 100 approvals. those trials serve three purposes, 1) to generate high quality data to support doctor choice, 2) provide defense for medical malpractice suits against doctors, and 3) support insurance reimbursement.

Doctors already have discretion to prescribe Tagrisso for the common flu. However, a doctor that does so will struggle to get insurance to cover it, and will have a harder defense if the patient sues.

Oh this is interesting. Basically any "unproven" remedy or treatment can be called upon by any doctor, if they're willing to forego insurance and some legal protection.

I was under the impression that patients having to "wait" for approvals would be missing out. But in theory you could get a lot of experimental treatments if you're willing to take the risk?

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