1. Pink Sheet

AstraZeneca Hopes Imfinzi Breakthrough Get Can Burn Off MYSTIC Failure

 
• By Bridget Silverman

Imfinzi becomes first cancer immunotherapy designated a breakthrough therapy for non-metastatic non-small cell lung cancer patients who have not progressed after platinum-based chemoradiation therapy, just days after announcing a missed primary endpoint in the first-line MYSTIC trial in metastatic NSCLC.

LungCancerCells_1200x675

A new breakthrough therapy designation (BTD) for AstraZeneca PLC's Imfinzi (durvalumab) signals FDA's confidence in the promise of the agent in non-metastatic non-small cell lung cancer, a setting earlier in the disease course than the metastatic NSCLC indications FDA has so far granted to immunotherapies.

The BTD is a welcome counterpoint to the disappointing results from the Phase III MYSTIC trial as first-line treatment for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from R&D

More from Pink Sheet

‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 
• By Bridget Silverman

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.