publication date: Jul. 20, 2018

Conversation with The Cancer Letter Novartis’s Hirawat: “It’s a continuous dialogue that goes on on a daily basis”  Samit_Hirawat

Samit Hirawat

Executive vice president and head of Global Oncology, Novartis


The two FDA pilot programs—Real-Time Oncology Review and Assessment Aid sped up the processing of Novartis’s supplemental new drug applications for Kisqali (ribociclib), said Samit Hirawat, executive vice president and head of Global Oncology at Novartis.

After the company informed FDA that they had locked the data from the MONALEESA 3 trial, FDA officials called with an offer: Would you like to test out a couple of our pilot programs?

“They basically said, ‘Submit the raw data to us, because we need to analyze it based on our own systems anyway.’” Hirawat said.

The result of this collaboration with FDA: the filing of company’s application for approval and the agency’s final action, an approval, occurred on the same day—July 18.


Hirawat spoke with Paul Goldberg, editor and publisher of The Cancer Letter.


Paul Goldberg:

It’s really rare to be able to look at the machinery of … Continue reading Novartis’s Hirawat: “It’s a continuous dialogue that goes on on a daily basis”

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