Novartis gains FDA priority review for ribociclib, as EMA accepts med

Novartis ($NVS) was given another boost today as it looks to make good on its blockbuster potential CDK 4/6 breast cancer med ribociclib after the FDA said it will now speed up its work on reviewing the med, as the EMA also begins its work on the drug.

Specifically, its candidate has been given the FDA sped-up priority review in conjunction with its older aromatase inhibitor med Femara (letrozole) as a first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer.

This lowers the time the FDA takes to come to a decision on a med from 10 months after filing to six months.

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The Big Pharma also announced that the EMA has accepted its drug for review in the same patient population.

Novartis is now closing in on becoming the second Big Pharma to market in the major blockbuster CDK 4/6 space after rival Pfizer ($PFE). It also comes after posting positive late-stage survival data at the ESMO cancer conference a few weeks back.

The figures for LEE011 (aka ribociclib) showed its experimental med, alongside Femara, significantly extended progression-free survival (PFS) compared to Femara alone as a first-line treatment in postmenopausal women with hormone receptor positive, HR+/HER2- advanced or metastatic breast cancer.

“These regulatory milestones, along with the FDA Breakthrough Therapy designation granted in August, underscore the need for new treatment options for women living with HR+/HER2- advanced breast cancer,” said Bruno Strigini, CEO of Novartis Oncology.

“Priority Review allows a shorter review period compared with FDA standard review in the US, helping us to potentially bring LEE011 plus letrozole to patients more quickly. We also are working diligently with the EMA and other health authorities to bring this treatment to patients around the world as fast as possible.”

This has also been a boon for U.K. biotech Astex Pharmaceuticals, which has been handed a milestone payment for the filing. Ribociclib was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collab with Astex.

The biotech can also look forward to further milestone payments if and when filings and approvals in Europe and Japan happen, as well as royalty payment on annual sales of ribociclib. 

After ditching much of its gene and cell therapy work in the summer, the Swiss major in its recent financials touted ribociclib as one of its top prospects.

Pfizer’s first-to-market Ibrance (palbociclib) and ribociclib are expected to be making blockbuster sales, with $1 billion in peak annual revenue slated for Novartis--while some analysts see nearly $6 billion for Pfizer’s med at peak. 

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