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US Filing For AZ’s Imfinzi In Stage III Lung Cancer

 
• By Maureen Kenny

Important US filing goes ahead as AstraZeneca submits sBLA for Imfinzi in earlier-stage non-small cell lung cancer.

USA & EU
Imfinzi in Stage III NSCLC is now in the hands of both EU and US regulators • Source: Shutterstock

AstraZeneca has filed for approval in the US of its PD-L1 blocker, Imfinzi (durvalumab), in the important indication of Stage III non-small cell lung cancer, just weeks after doing the same in the EU.

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More from United States

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
• By Sue Sutter

Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.

PBMs No Longer Profit From Rebates But Plans Benefit; Should Sponsors Push More For Reform?

 
• By Cathy Kelly

Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.

More from North America

US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.

Another Regeneron CRL Prompts Regulatory Operations Questions

 
• By Alaric DeArment

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.