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AstraZeneca’s Imfinzi Squeezes Through: Is FDA Reversing Course Or In A Transition Period?

 
• By Sarah Karlin-Smith

Even as US FDA expressed concern about the perioperative trial design, AstraZeneca’s ability to snag NSCLC indication without demonstrating the benefits of both the neoadjuvant and adjuvant phases of therapy highlights slow pace of agency policy shifts.

series of doors starting with each door being more open than the last
Imfinzi's perioperative NSCLC indication got through FDA on a data set that may soon shut other sponsors out. • Source: Shutterstock

AstraZeneca PLC’s Imfinzi became the second cancer immunotherapy approved for perioperative use in resectable non-small cell lung cancer (NSCLC) on 15 August, despite the US Food and Drug Administration’s prior suggestion that the first immunotherapy approved for this use, Merck & Co.’s Keytruda may have been a mistake.

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More from Post-Marketing Regulation & Studies

Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 
• By Eliza Slawther

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

Pharma Industry Wants Easier Access To England’s Revamped NHS Data Sharing System

 
• By Eliza Slawther

The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.

US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

 
• By Ramsey Baghdadi

Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents.

Shorter Gene Therapy Postmarket Studies ‘On The Table’

 
• By Derrick Gingery

Amid complaints about the challenges of following gene therapy patients for up to 15 years, OTP Director Nicole Verdun said the FDA is considering how to conduct long-term postmarket studies more efficiently.

More from Product Reviews

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

 
• By Neena Brizmohun

Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.