Luca Dezzani: We are requesting approval from the U.S. FDA EGFR-mutated NSCLC therapy

Luca Dezzani, Vice President of US Oncology Medical Affairs at Johnson & Johnson, shared a post by Biljana Naumovic, President of US Oncology Solid Tumor at Johnson & Johnson Innovative Medicine, on LinkedIn adding:

“I’m excited to share we are requesting approval from the U.S. FDA for a new
subcutaneous formulation of our EGFR-mutated non-small cell lung cancer (NSCLC) therapy.

This FDA submission highlights our commitment to transforming treatment experiences for patients and their loved ones, as well as for oncologists and nurses.

Learn more about this news here.”

Quoting Biljana Naumovic’s post:

“It’s shaping up to be an exciting year for our oncology team at Johnson & Johnson Innovative Medicine!

I am proud to share that we’ve submitted a Biologics License Application (BLA) to the FDA for the subcutaneous formulation of our EGFR-mutated non-small cell lung cancer (NSCLC) targeted therapy.

This application is based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with a five-minute subcutaneous administration.

On top of this remarkable benefit for patients, we have also seen efficacy results in PALOMA3 that have not been seen before in a study assessing IV and SC comparability.

We understand that a cancer diagnosis can lead to a complex treatment journey.

That’s why our vision is to provide personalized medicine that is not only effective, but also improves the overall treatment experience for patients.

Thank you to all who contributed to this monumental milestone!

I encourage you to read the press release!”

Source: Luca Dezzani/LinkedIn and Biljana Naumovic/LinkedIn