Last Update 11:0
Sunday, 17 November 2019

FDA clears radioactive drug for cancer that killed Steve Jobs

The injection works by hitting cancer cells with high energy electrons, just like radiotherapy, but targets tumors that over-express a certain protein.

Reuters , Saturday 27 Jan 2018
Views: 8630
Views: 8630

The U.S. Food and Drug Administration on Thursday approved a radioactive drug to treat the ultra-rare type of digestive tract cancer that killed Steve Jobs in 2011.

The approval for Advanced Accelerator Applications SA’s Lutathera comes just days after Swiss giant Novartis AG closed its $3.9 billion acquisition of the French company.

Lutathera is unusual in that it harnesses the same molecule that is used to diagnose cancer to also deliver the treatment.

The radiopharmaceutical injection works by hitting cancer cells with high energy electrons, just like radiotherapy, but targets gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that over-express a certain protein.

Advanced Accelerator said Lutathera’s list price is about $47,500 per dose, with the usual treatment period including four doses. This price is not necessarily what patients actually pay, as out-of-pocket costs vary based on a patient’s insurance plan and rebates offered by drugmakers.

The treatment reduced the risk of the disease progressing by 79 percent in a late-stage clinical trial, on the basis of which it was approved, Accelerator Applications said.

In general, patients with well-and-moderately differentiated tumors, compared with healthy cells, have a roughly 35 percent probability of surviving for five years, the company estimates.

This is the first U.S. approval for this kind of treatment, known as peptide receptor radionuclide therapy. The European Medicines Agency approved Lutathera in September and Novartis offered to buy Advanced Accelerator a month later.

The FDA estimates that each year, one out of 27,000 people are diagnosed with GEP-NETs, a disease that killed Apple co-founder Jobs in 2011.

It has been a long journey for Lutathera. The FDA rejected the drug in 2016, asking for more study data. The company resubmitted its marketing application in July last year.

Short link:


Ahram Online welcomes readers' comments on all issues covered by the site, along with any criticisms and/or corrections. Readers are asked to limit their feedback to a maximum of 1000 characters (roughly 200 words). All comments/criticisms will, however, be subject to the following code
  • We will not publish comments which contain rude or abusive language, libelous statements, slander and personal attacks against any person/s.
  • We will not publish comments which contain racist remarks or any kind of racial or religious incitement against any group of people, in Egypt or outside it.
  • We welcome criticism of our reports and articles but we will not publish personal attacks, slander or fabrications directed against our reporters and contributing writers.
  • We reserve the right to correct, when at all possible, obvious errors in spelling and grammar. However, due to time and staffing constraints such corrections will not be made across the board or on a regular basis.

© 2010 Ahram Online.