In surprise move, FDA rejects cancer drug expected to rival Novartis therapy
The Food and Drug Administration has rejected a radiopharmaceutical therapy due to manufacturing issues, halting what would have been a competitor for Novartis.
The drug, ITM-11, had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field. Radiopharmaceuticals are an emerging type of treatment designed to shoot radioactive isotopes directly at tumor cells.
ITM’s therapy was designed to treat gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, a rare type of cancer that grows in the pancreas, stomach, small intestine, and other parts of the gastrointestinal system. ITM reported in March 2025 that patients with the earliest forms of this cancer who received ITM-11 infusions lived for 23.9 months without their tumors growing. Meanwhile, patients taking another treatment on the market, everolimus, went a median 14.1 months before their cancer progressed.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in
View All Plans
To read the rest of this story subscribe to STAT+.
Subscribe
PakarPBN
A Private Blog Network (PBN) is a collection of websites that are controlled by a single individual or organization and used primarily to build backlinks to a “money site” in order to influence its ranking in search engines such as Google. The core idea behind a PBN is based on the importance of backlinks in Google’s ranking algorithm. Since Google views backlinks as signals of authority and trust, some website owners attempt to artificially create these signals through a controlled network of sites.
In a typical PBN setup, the owner acquires expired or aged domains that already have existing authority, backlinks, and history. These domains are rebuilt with new content and hosted separately, often using different IP addresses, hosting providers, themes, and ownership details to make them appear unrelated. Within the content published on these sites, links are strategically placed that point to the main website the owner wants to rank higher. By doing this, the owner attempts to pass link equity (also known as “link juice”) from the PBN sites to the target website.
The purpose of a PBN is to give the impression that the target website is naturally earning links from multiple independent sources. If done effectively, this can temporarily improve keyword rankings, increase organic visibility, and drive more traffic from search results.
