Robert Francomano: Significant change in regulatory priorities by the FDA

Robert Francomano, Chief Commercial Officer at SELLAS, shared on LinkedIn:

“The recent emphasis by the FDA on considering overall survival (OS) over progression-free survival (PFS) when evaluating cancer drug approvals marks a significant change in regulatory priorities.

It showcases the agency’s dedication to ensuring that medications deliver advantages. This adjustment presents both challenges and opportunities for smaller biotech firms that are under growing pressure to prove the benefits of OS.

It highlights the balance between fostering innovation and providing solid evidence of positive long-term outcomes for patients. This article from BioSpace explores how this shift impacts the development, approval process, and market dynamics of cancer therapies.”

Procced to the article.
Source: Robert Francomano/LinkedIn