Dive Brief:
- Novartis has suspended production of two cancer drugs at plants in Italy and New Jersey due to “potential quality issues” it identified in its manufacturing processes. As a result, the Swiss pharmaceutical company will temporarily stop delivering the two drugs, sold as Lutathera and Pluvicto, while it works to address the problem.
- The company disclosed the production halt in a statement Thursday, which described its decision as one made “out of the abundance of caution.” Novartis said there is no indication of risk to patients treated with drug product previously made at either of the sites and has asked treatment centers to monitor for any side effects.
- Lutathera and Pluvicto, which respectively treat digestive tract and prostate cancers, are what’s known as radiopharmaceuticals — made by combining a radioactive particle with a compound called a ligand that helps guide the medicine to cancer cells.
Dive Insight:
Novartis’ announcement follows a little over one month after the Food and Drug Administration approved Pluvicto for prostate cancer, a clearance that helped validate the drugmaker’s $2.1 billion purchase of the treatment’s original developer, Endocyte, in 2018.
The pharma forecasts annual sales up to or exceeding $1 billion for both Pluvicto and Lutathera, which together represent a major bet by Novartis on nuclear medicine. (Lutathera also came via an acquisition, of Advanced Accelerator Applications in 2017.)
The two drugs are the product of one of several newer drugmaking technologies Novartis has invested in under CEO Vas Narasimhan, alongside cell, gene and RNA therapies.
But radiopharmaceuticals are more complex to manufacture than standard small molecule pills and even biologic drugs, which are now commonplace across the industry.
Novartis did not detail the potential quality issue it identified in its statement and a spokesperson declined to offer further information when contacted by BioPharma Dive.
“Novartis is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks,” the company said.
Some doses of Lutathera will be available in Europe and Asia as Novartis also makes that drug at a production facility in Spain, although the company indicated there could still be supply delays.
In addition to halting production and delivery of Pluvicto and Lutathera made for commercial sale, Novartis will temporarily suspend patient screening and enrollment for clinical trials testing Lutathera in the U.S. and Canada as well as the experimental version of Pluvicto worldwide.
While Novartis has emphasized new technologies, it has run into production issues turning them into large-scale drugmaking platforms before. For example, some patients treated with its CAR-T therapy Kymriah received drug product that, while safe and effective, didn’t meet commercial standards and therefore couldn’t be charged.
