New Products

Novartis scores a quick FDA OK for its new cancer drug Lutathera, picked up in $4B buyout

It didn’t take long for Novartis’ $NVS $4 billion acquisition of Advanced Accelerator Applications to pay off. The FDA has provided its stamp of approval for their drug Lutathera, which uses radioisotopes to target certain neuroendocrine tumors.

Vasant Narasimhan, Novartis

The pivotal data for the drug — used to treat gastroenteropancreatic neuroendocrine tumors that affect the pancreas or gastrointestinal tract — from the NETTER-1 study demonstrated a 79% reduction in the risk of disease progression, with an interim median progression-free survival rate of 8.4 months that had yet to max out. The FDA had initially batted back the application on Lutathera at the end of 2016, asking for some additional work on the data, which delayed the approval.

There are about 7 cases of these tumors per 100,000 people in the US, a group which included Apple founder Steve Jobs.

Now Novartis — which bought out the French biotech in late October — can build on their OK for Afinitor in early 2016 as a treatment for neuroendocrine tumors, as well as its marketing of Sandostatin. The Basel-based pharma giant also scored a pipeline that includes 177Lu-PSMA-R2, which is now entering a Phase I/II study.

Susanne Schaffert

The deal represents a sweet spot for the company as Vas Narasimhan transitions to the top job at the company. Execs want to stick with economical bolt-ons like this with a clear commercial payback in the cards.

“As the first PRRT (Peptide Receptor Radionuclide Therapy) ever approved in the US, Lutathera is introducing a major advancement in the treatment paradigm for these patients that we hope will improve many lives,” said AAA president Susanne Schaffert. “We believe nuclear medicine has the potential to offer many benefits to cancer patients and will use this approval as a foundation for the development of additional targeted cancer treatments utilizing radiolabeled ligands.”

Baader Helvea analyst Bruno Bulic has been bullish on this drug, noting its potential for replacing Sandostatin and going on to earn about $2 billion in peak sales.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,100+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->