Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA?

 
• By Alaric DeArment
  
Generate a summary of this article
Listen to this article
Beta

Sorrento plans to meet with the US FDA regarding abivertinib, but the agency’s tough stance on drug approvals based on single-country studies could thwart the company’s efforts.

Sorrento's intention to go to the FDA raise the question of how the agency will view its China-only data • Source: Shutterstock

Sorrento Therapeutics, Inc.’s pivotal Phase I/II trial data for abivertinib in non-small cell lung cancer (NSCLC) looks compelling and, at least on the surface, would seem to have a decent shot at supporting US Food and Drug Administration approval. But since the trial was conducted solely in China, the company is in conflict with the agency’s latest thinking on single-country studies.

In recent months, the FDA has taken a negative view toward granting approvals based on China-only studies, prompting EQRx,...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from US FDA

PS-AgencyLeadership (Premium-1): Study Reveals How Immune System of Astronauts Breaks Down

Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.

Nancy Test Circulable Section Geography

 
• By Brian Bossetta

This is a short description

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

More from Agency Leadership

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.