https://www.cidrap.umn.edu/resilien...-drug-shortage-should-ease-soon-novartis-says
Prostate cancer drug shortage should ease soon, Novartis says
Mary Van Beusekom, MS
Today at 12:51 p.m.
Resilient Drug Supply
In April, Novartis AG announced that the US Food and Drug Administration (FDA) had approved manufacture of the drug (generic name, lutetium Lu 177 vipivotide tetraxetan injection) at a new facility in Millburn, New Jersey, in addition to its Ivrea, Italy, plant.
"Production will begin in the coming weeks and ramp up gradually," the announcement said. "The site is expected to contribute meaningfully to supply and sales in the third quarter, after the anticipated approval of additional lines at the site. Capacity should continue to increase through the second half of this year, helping to ensure stable, reliable supply to patients."
Drug can't be stockpiled
In February, Novartis told NBC News that it had paused taking new orders after Pluvicto supplies dwindled amid increased demand. The drug is made in small batches that must be used within 5 days and thus can't be stockpiled. Pluvicto has been on the FDA's drug shortage list since March 7.
David Margraf, PharmD, PhD, pharmaceutical research scientist at the Resilient Drug Supply Project (RDSP), said that the shortage is primarily due to the difficulty of producing lutetium-177, a key component of the drug. RDSP is part of the University of Minnesota's Center for Infectious Disease Research and Policy, publisher of CIDRAP News.
"Lutetium metal is a rare, difficult-to-produce, and expensive element, which then requires complex and time-consuming synthesis in a nuclear reactor to produce the radioisotope, lutetium-177," he said.
Lutetium metal is a rare, difficult-to-produce, and expensive element, which then requires complex and time-consuming synthesis in a nuclear reactor to produce the radioisotope, lutetium-177.
David Margraf, PharmD, PhD
Pluvicto has a short physical, or radioactive half-life of 6.6 days. "Another factor contributing to the shortage of Pluvicto is the limited production capacity of the single facility in Italy that binds lutetium-177 to other molecules," Margraf said.
The drug has no therapeutic equivalents, meaning that some prostate cancer patients have been unable to secure their only treatment option.
In March 2022, the FDA approved Pluvicto for the treatment of prostate cancer patients with advanced disease who had already received androgen receptor pathway inhibition and taxane-based chemotherapy. The approval was based on clinical trial results showing improved overall survival and radiographic progression-free survival.
Plant expansions, new facilities
Novartis said that its plant in Italy will continue to supply the US market and that an expansion at that site is under way.
"A new facility in Indianapolis, Indiana, is nearing completion, and is expected to open as soon as the end of this year," the company said in its announcement. "In addition, Novartis has received approval for the Zaragoza, Spain, site to supply the EU market. We expect this site to ramp up gradually over the coming months. With these sites, a capacity of at least 250k doses of Pluvicto annually is targeted in 2024+."
"There is a growing demand for lutetium-177–containing drugs in nuclear medicine," Margraf said. "To address the shortage of Pluvicto, a more coordinated effort must be made to ensure a stable supply of lutetium-177."
"This could involve increasing the production capacity of the facility that produces Pluvicto, creating new production facilities, as well as exploring new methods for synthesizing lutetium-177 that are more efficient and cost-effective," he added.
Pluvicto is one of five major cancer drugs in shortage in the United States, including methotrexate, cisplatin, fluorouracil, and Bacillus Calmette-Guerin (BCG).
Prostate cancer drug shortage should ease soon, Novartis says
Mary Van Beusekom, MS
Today at 12:51 p.m.
Resilient Drug Supply
Supplies of Pluvicto, a radioactive drug used to treat metastatic prostate cancer, should rise "meaningfully" in the second half of this year, according to its lone manufacturer.In April, Novartis AG announced that the US Food and Drug Administration (FDA) had approved manufacture of the drug (generic name, lutetium Lu 177 vipivotide tetraxetan injection) at a new facility in Millburn, New Jersey, in addition to its Ivrea, Italy, plant.
"Production will begin in the coming weeks and ramp up gradually," the announcement said. "The site is expected to contribute meaningfully to supply and sales in the third quarter, after the anticipated approval of additional lines at the site. Capacity should continue to increase through the second half of this year, helping to ensure stable, reliable supply to patients."
Drug can't be stockpiled
In February, Novartis told NBC News that it had paused taking new orders after Pluvicto supplies dwindled amid increased demand. The drug is made in small batches that must be used within 5 days and thus can't be stockpiled. Pluvicto has been on the FDA's drug shortage list since March 7.
David Margraf, PharmD, PhD, pharmaceutical research scientist at the Resilient Drug Supply Project (RDSP), said that the shortage is primarily due to the difficulty of producing lutetium-177, a key component of the drug. RDSP is part of the University of Minnesota's Center for Infectious Disease Research and Policy, publisher of CIDRAP News.
"Lutetium metal is a rare, difficult-to-produce, and expensive element, which then requires complex and time-consuming synthesis in a nuclear reactor to produce the radioisotope, lutetium-177," he said.
Lutetium metal is a rare, difficult-to-produce, and expensive element, which then requires complex and time-consuming synthesis in a nuclear reactor to produce the radioisotope, lutetium-177.
David Margraf, PharmD, PhD
Pluvicto has a short physical, or radioactive half-life of 6.6 days. "Another factor contributing to the shortage of Pluvicto is the limited production capacity of the single facility in Italy that binds lutetium-177 to other molecules," Margraf said.
The drug has no therapeutic equivalents, meaning that some prostate cancer patients have been unable to secure their only treatment option.
In March 2022, the FDA approved Pluvicto for the treatment of prostate cancer patients with advanced disease who had already received androgen receptor pathway inhibition and taxane-based chemotherapy. The approval was based on clinical trial results showing improved overall survival and radiographic progression-free survival.
Plant expansions, new facilities
Novartis said that its plant in Italy will continue to supply the US market and that an expansion at that site is under way.
"A new facility in Indianapolis, Indiana, is nearing completion, and is expected to open as soon as the end of this year," the company said in its announcement. "In addition, Novartis has received approval for the Zaragoza, Spain, site to supply the EU market. We expect this site to ramp up gradually over the coming months. With these sites, a capacity of at least 250k doses of Pluvicto annually is targeted in 2024+."
"There is a growing demand for lutetium-177–containing drugs in nuclear medicine," Margraf said. "To address the shortage of Pluvicto, a more coordinated effort must be made to ensure a stable supply of lutetium-177."
"This could involve increasing the production capacity of the facility that produces Pluvicto, creating new production facilities, as well as exploring new methods for synthesizing lutetium-177 that are more efficient and cost-effective," he added.
Pluvicto is one of five major cancer drugs in shortage in the United States, including methotrexate, cisplatin, fluorouracil, and Bacillus Calmette-Guerin (BCG).