Top Line: A shortage of Pluvicto has led Novartis to halt new patient starts in order to supply patients actively receiving treatment.
The Story: If you thought your March Madness bracket looked bad, just compare it with the timeline for rolling out Pluvicto. With great excitement, we learned back at ASCO 2021 that the targeted radiopharmaceutical, Lu177-PSMA or Pluvicto, improved overall survival in men with metastatic castration resistant prostate cancer who progressed on ADT, an androgen receptor pathway inhibitor, and docetaxel. While many other targeted agents get accelerated approval with far less impressive results, it took almost a year for the FDA to approve Pluvicto. During this time, a large population of patients began to accumulate with great hope that this drug would help extend their survival. Unfortunately, it soon became apparent that Pluvicto was hard to come by. We’ve personally seen patients with refractory mCRPC wait 2-3 months to get a first dose. Earlier in March, the manufacturer Novartis posted on the FDA website that there was shortage of Pluvicto that could last at least 4 months. Novartis has also recently canceled doses for new patients. Due to the lack of supply, they can only provide enough doses for existing patients. Currently, Pluvicto supplies for the US are produced at a single facility in Italy. That’s right, a drug with a half-life of 6.6 days has to make it from Italy to your local center. There’s another facility in New Jersey that apparently supplies Canada but is awaiting FDA authorization to supply its own country. A source of delay in expanding production may have been FDA concerns about manufacturing quality issues. Also, Novartis apparently didn’t anticipate such a large demand for a drug that improves survival in patients who usually have no other treatment options.
TBL: A year after FDA approval and nearly 2 years after reporting of the VISION trial, patients with refractory mCRPC cannot start treatment with the life prolonging therapy Pluvicto due to shortages from production. | Novartis, 2023
The Story: If you thought your March Madness bracket looked bad, just compare it with the timeline for rolling out Pluvicto. With great excitement, we learned back at ASCO 2021 that the targeted radiopharmaceutical, Lu177-PSMA or Pluvicto, improved overall survival in men with metastatic castration resistant prostate cancer who progressed on ADT, an androgen receptor pathway inhibitor, and docetaxel. While many other targeted agents get accelerated approval with far less impressive results, it took almost a year for the FDA to approve Pluvicto. During this time, a large population of patients began to accumulate with great hope that this drug would help extend their survival. Unfortunately, it soon became apparent that Pluvicto was hard to come by. We’ve personally seen patients with refractory mCRPC wait 2-3 months to get a first dose. Earlier in March, the manufacturer Novartis posted on the FDA website that there was shortage of Pluvicto that could last at least 4 months. Novartis has also recently canceled doses for new patients. Due to the lack of supply, they can only provide enough doses for existing patients. Currently, Pluvicto supplies for the US are produced at a single facility in Italy. That’s right, a drug with a half-life of 6.6 days has to make it from Italy to your local center. There’s another facility in New Jersey that apparently supplies Canada but is awaiting FDA authorization to supply its own country. A source of delay in expanding production may have been FDA concerns about manufacturing quality issues. Also, Novartis apparently didn’t anticipate such a large demand for a drug that improves survival in patients who usually have no other treatment options.
TBL: A year after FDA approval and nearly 2 years after reporting of the VISION trial, patients with refractory mCRPC cannot start treatment with the life prolonging therapy Pluvicto due to shortages from production. | Novartis, 2023