🚨🔥@OncoAlert Hot off the press. ⭐️@FDA approves: ❇️#Reduced #MonitoringTime for first two doses of #Tarlatamab in #SmallCell #LungCancer. ⏳22-24 hrs ➡️ 6-8 hrs. Important update/change that supports broader #access & ⬇️complexity for #Patients. 👇🏻 amgen.com/newsroom/press-rel…

📢 #SCLC news: Amgen announced that a Phase 3 study evaluating its DLL3-targeting therapy as part of first-line maintenance treatment for patients with extensive-stage small cell lung cancer met its primary endpoint ➡️ Learn more: amgen.ly/4ihHq5p $AMGN

We are on the cusp of a wave of new therapies for some of the worst diseases. But the world won’t benefit unless the US fixes its drug regulatory system. My new essay for @nytimes, on how slow clinical trials are now the biggest obstacle to curing cancer. nytimes.com/2026/09/04/opini… - I interviewed dozens of researchers, especially oncologists at leading U.S. centers. A striking consensus emerged: science is no longer the main bottleneck to new cancer drugs. It is our ability to test discoveries in patients through clinical trials. - The cost of starting a Phase 1 trial in America has roughly doubled over the past decade. As a result, companies increasingly take early trials abroad: Australia’s Phase 1 trial volume has nearly doubled in a decade, driven mainly by U.S. companies. - Unfortunately, the underlying incentives are badly asymmetric: Institutions can be blamed for harms caused by moving too fast, but almost no one is blamed when patients deteriorate during avoidable delays. One doctor called the emerging system “ritualized safety over actual risk assessment.” Or as, @DavidHongMD put it: "We often forget that the biggest risk is the cancer itself." - This problem is becoming more urgent because medicine itself is changing. Sequencing, biological engineering and A.I. make increasingly personalized therapies possible. But our regulatory system was mostly built for standardized drugs tested in large populations. - @sytse, the co-founder of GitLab, shows what personalized medicine can achieve: after relapsed osteosarcoma and being told there were no options left, he pursued a highly individualized approach and has now been cancer-free for a year. But doing so required extraordinary resources and regulatory expertise. - Pierce Ogden’s father was less lucky. After molecular analysis identified a drug that might target his glioblastoma, the manufacturer agreed to provide it. But administrative barriers delayed access until it was too late. “My dad was ready to try anything,” Pierce told me. “But the system is paternalistic.” - The A.I. revolution is making this bottleneck more important, not less. A.I. relies on relevant data. Information from early-stage trials could compound with A.I. tools to achieve truly revolutionary medicines. Without the data, this is far less likely to happen. - Another important shift is that innovation increasingly comes from academic labs and small biotech companies rather than Big Pharma. These small companies find it far harder to unable to absorb delays and regulatory barriers. - Apart from cancer, China is the biggest winner from America's outdated medical regulations. China has a much faster trial system, with testing often starting a full year earlier. This allows Chinese pharmaceutical companies to experiment and improve medicines while American companies play with mice. Today, half of all drugs licensed by major pharmaceutical companies originate there, up from less than 5 percent only a decade ago. - But we don't need to copy China. The best model is Australia: lots of on-site scientific and ethics reviews, and requirements that are proportionate to small, early-stage trials. Phase 1 studies there begin roughly 6–12 months faster, without any notable increases in adverse safety events. - Operation TrialBlazer, a 2026 HHS initiative is a good start in this direction, but we need legislative action by Congress to truly make Phase I trials faster and more efficient! I want to thank everyone who helped me with this article: everyone I interviewed and the amazing editors at the Times. This is the result of a months long journey of extensive interviews and research. Special thanks go to those who came on the record. One of the features of the system is an atmosphere of fear, where practitioners are afraid to publicly come out and explain these issues. So anyone who does is a hero in my book!