Tag: News Approved

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STAT+: Akeso and Summit’s ivonescimab extends survival in squamous cell lung cancer

CHICAGO — Ivonescimab, a drug that combines the activity of two of the best-selling cancer medicines, reduced the risk of death in patients with squamous non-small cell lung cancer by 34% compared to a standard treatment in a clinical trial conducted entirely in China by the drug’s developer, Akeso Therapeutics, according to data presented Sunday.

The result, oncologists say, exceeded their expectations, and it appears it could generate optimism for the drug, which is being developed outside China by Summit Therapeutics. But the data also are likely to fuel debate on issues like the role of China in drug development and the future of cancer treatments. The results were presented here at the annual meeting of the American Society of Clinical Oncology and are being published simultaneously in The Lancet.

Robert Duggan, Summit’s co-CEO and chairman, said that the data mean the company has “a very valuable business with a very valuable product that is in its early stages.” Akeso had no comment for this story.

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STAT+: BioNTech and Pfizer tout bispecifics data, and Pazdur sees silver lining at FDA

You’re reading the web edition of ASCO in 30 Seconds, STAT’s guide to the American Society of Clinical Oncology annual meeting. Sign up for email editions here.  

A huge thanks to everyone who attended the jam-packed STAT @ ASCO event last night. The bao buns were incredible. IYKYK.

Don’t forget to sign up for our ASCO virtual recap on Wednesday.

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STAT+: China competition, ‘destruction’ at FDA give agency chance to restructure, Rick Pazdur says

CHICAGO — Rick Pazdur, the former top oncology regulator at the Food and Drug Administration, said the damage done under recent political appointees opens a chance for new leadership to fundamentally restructure the FDA, particularly as China’s drug industry grows more competitive. 

Under leaders appointed by the Trump administration, “we’ve had a lot of destruction here, and it doesn’t mean that we have to just go back and say, well, let’s rebuild it as it was,” Pazdur said Friday night at a STAT event during the annual meeting of the American Society of Clinical Oncology. “This gives us a great opportunity of — how we want to build it, what staff we want to have, how we want the administrative structure to be.”

He said the FDA has lost many valuable experts and one way to bolster the workforce is to “think creatively,” such as bringing in academics and people in the drug industry for one- or two-year terms.

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STAT+: Revolution Medicines starts shipping experimental pancreatic cancer drug

CHICAGO — The biotech company Revolution Medicines has begun sending its experimental, life-extending treatment for pancreatic cancer to physicians and their patients under an early access program authorized by the Food and Drug Administration, the company’s CEO, Mark Goldsmith, told STAT.

“We are now shipping the drug,” he said, speaking Friday evening at a STAT event held in conjunction with the annual meeting of the American Society of Clinical Oncology. 

The drug, daraxonrasib, is not yet approved. But patients with pancreatic cancer have been clamoring for it since mid-April, when Revolution reported the striking results of a Phase 3 clinical trial. Patients treated with daraxonrasib lived nearly twice as long as patients offered standard chemotherapy — an outcome unprecedented in the pancreatic cancer field. 

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STAT+: As Ebola outbreak grows, Trump administration veers from previous government playbook

WASHINGTON — In January 2025, with the Covid-19 pandemic still top of mind, the Biden administration left behind extensive plans for how the federal bureaucracy should work to stop future disease outbreaks.

The plans were hundreds of pages long and addressed dozens of specific issues, including the government response to diseases like Ebola and how to move Americans from outbreak zones back to the U.S. for care.

But weeks later, the Trump administration took Washington by storm — and began disregarding the plans, according to two former Centers for Disease Control and Prevention officials who worked in the Trump administration and four people familiar with the Biden-era plans.

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STAT+: At ASCO, positive data for Bristol in multiple myeloma and Pfizer in lung cancer

You’re reading the web edition of ASCO in 30 Seconds, STAT’s guide to the American Society of Clinical Oncology annual meeting. Sign up for email editions here.  

We’re ASCOmaxxing.

Rest assured, this will not require Adam Feuerstein, Matthew Herper or Angus Chen to hammer on their jawlines. They will, however, be scouring the ASCO annual meeting to bring you the cancer news, analysis and event coverage you crave.

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<![CDATA[Phase 2 data suggest luvesilocin quickly eases postpartum depression with durable remission and minimal breast‑milk transfer, supporting larger trials.]]>
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STAT+: Trump administration seeks to overhaul federal grantmaking process, alarming researchers

The Trump administration has released a sweeping proposal to overhaul the bedrock regulation for all federal grants, and in doing so is seeking to codify tighter political control of federally funded research. 

The changes, laid out in a 400-plus-page document published this week, would deemphasize the role of peer review in determining what work to fund, limit the ability for scientists to use federal funds to publish their research or travel to conferences, and offer political appointees more latitude to terminate grants at will.

The suite of proposed changes aligns in many respects with policies the administration has attempted to implement through executive orders and one-off announcements, sometimes at individual agencies; if formalized, the revised regulation would be in effect across the government and put the regulatory authority of the White House behind it. 

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<![CDATA[Phase 3 at-home data show sublingual dexmedetomidine cuts severe agitation in bipolar disorder and schizophrenia, supporting FDA label expansion.]]>