TUESDAY, March 21, 2023 (HealthDay News) — An ongoing shortage of a drug for men with advanced prostate cancer is causing some patients to miss months of probably life-extending treatment.

The drug’s maker, Novartis Pharmaceuticals Corp., has said it could’t sustain with demand for the medication, often called Pluvicto.

Doctors have needed to reschedule some patients who were as a consequence of start their first doses of the treatment. Meanwhile, the corporate said it’s prioritizing those that are already being treated with six cycles of the drug, but even a few of those patients haven’t been in a position to get their medication.

“We recognize that any rescheduled dose is distressing for patients and their family members and poses challenges for the treatment centers. We’re striving to function many patients as possible as quickly as possible as we work through the present situation,” Novartis said in a recent news release.

Amongst U.S. men, prostate cancer is the second commonest cancer and the second leading reason for cancer death. About 34,700 Americans die from the disease annually, in response to the American Cancer Society.

Prostate cancer has no cure at this advanced stage. Pluvicto was designed to treat metastatic castration-resistant prostate cancer with targeted radioligand therapy, according to the corporate. The medication delivers radiation to targeted cells using radioactive atoms.

The drug’s entry into the marketplace was approved by the U.S. Food and Drug Administration in March 2022, and its arrival was met with a whole lot of excitement, Dr. Daniel Spratt, chair of the department of radiation oncology at University Hospitals Seidman Cancer Center in Cleveland, told CNN.

“Some men and their physicians will feel that some hope was taken from them,” Spratt said. “Cancer is the enemy here, not the corporate, but it surely’s unlucky to have that excitement that your physician will have the ability to prescribe it to you and just not have the ability to offer it to them.”

Novartis said it makes the medication for U.S. patients at its plant in Ivrea, Italy. It suspended production last May due to “an abundance of caution” over potential quality issues, CNN reported. It also suspended production at its plant in Recent Jersey, where it makes the drug for the Canadian marketplace.

Production restarted at each plants last June, CNN reported.

Novartis has also recently accomplished its filing to make the drug for U.S. patients at its Recent Jersey plant, and it is usually constructing a plant in Indianapolis, with production possible there by the top of the yr.

The FDA told CNN that it “isn’t in a position to discuss details regarding any possible communications or actions with firms as a consequence of business confidential information.”

“To be clear, FDA doesn’t manufacture, produce, bottle or ship drugs and can’t force firms to accomplish that or make more of a drug. Nonetheless, normally, the FDA works with firms making drugs in shortage to assist them ramp up production in the event that they are willing to accomplish that. Often, they need recent production lines approved or need recent raw material sources approved to assist increase supplies. FDA can and does expedite review of those to assist resolve shortages of medically vital drugs,” the FDA said.

The Pluvicto shortage also signifies that the medication isn’t available for research, equivalent to whether the drug can also help patients before their cancer is advanced, CNN reported.

“We’re anxious to have greater supply to review it in broader populations,” Dr. William Dahut, chief scientific officer on the American Cancer Society, told CNN.

Dahut noted the impact of the drug on certain patients. A study from a Novartis trial found that individuals who received the treatment lived a median of about 15 months after diagnosis, 4 months longer than those without the treatment. And for some, it was much more impactful.

“There are some patients that actually do have those type of miraculous responses, so it does occasionally give us one in every of those ‘wow’ moments,” Dahut said.

More information

The U.S. National Cancer Institute has more on prostate cancer.

SOURCES: Novartis Pharmaceuticals Corp., news release, March 9, 2023; CNN