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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

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

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.

More from Product Reviews

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 
• By Bridget Silverman

All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote