The United States has a shortage of medicines that could help people suffering from advanced prostate cancer.
Pluvicto is a drug that treats metastatic castration resistant prostate cancer. Its maker Novartis said it could not produce any more until it produces more. People who were about to receive their first doses of Pluvicto had to be rescheduled.
We recognize that patients and their loved ones can be upset by any rescheduled dose and it poses challenges for treatment centers. Novartis stated that it is working to provide the best possible care for patients and their loved ones as they deal with the current situation. The company released a March 9 news release, which Novartis claimed was the most recent information.
According to the Swiss company, it had been in touch with US providers and treatment centers and is now 'actively engaging with them' in order to schedule rescheduling.
Novartis' manufacturing plant in Ivrea (Italy) is unable to keep up with the demand for the drug. It had to stop production at the facility in May because it was concerned about possible quality problems. It also stopped production at the New Jersey facility that produces the drug for Canada.
In June, Novartis resumed production in both plants.
Although the company is hopeful that the New Jersey facility will be authorized to manufacture the drug for the US, it is not yet clear when. Novartis stated in March that it had received approval from the US Food and Drug Administration.
A person with a terminal cancer has no time to wait for Novartis to make more. They also don't have many options. According to Dr. Daniel Spratt of the Department of Radiation Oncology, University Hospitals Seidman Cancer Center, Cleveland, Novartis won't be able to approve the New Jersey plant until too late.
Novartis stated that it prioritizes patients who are being treated with Pluvicto. The drug is administered in six cycles. Spratt stated that the supply of Pluvicto has been reduced recently, even for some of these patients.
He said that many patients were missing months of therapy. "The real tragedy is patients who are partially under treatment and have received great responses, but we can't get them the remainder of their therapy in the time frame.
According to the American Cancer Society, prostate cancer is second only to skin cancer. While prostate cancer is not the most common form of cancer in men, it is expected that 34,700 people will die this year. It is the second most common cause of death from cancer in American men, after lung cancer.
Pluvicto, a targeted radioligand treatment, uses radioactive atoms in order to deliver radiation to specific cells. This helps fight cancer and minimizes damage to surrounding tissues.
Although there is no cure for advanced cancer, Pluvicto may help people live longer. Spratt stated that there was excitement when the FDA approved Pluvicto in March 2022. Spratt said that patients who heard about the trials had been asking questions about it for years.
A Novartis trial found that patients who received the drug lived an average of 15 months, four months longer than those who did not. The recovery process is more dramatic for a few people.
Dr. William Dahut is chief scientific officer of the American Cancer Society.
Dahut stated that doctors like Pluvicto as it is easy to administer, and has very few side effects other than dry mouth.
The shortage has a side effect in that it slows down research. Some indications suggest that the drug may be able to help patients before their cancer progresses to a more advanced stage.
Dahut stated, "We are anxious to have more supply to study it with broader populations,"
Spratt stated that he works closely with his medical oncologists to seek out alternative treatments. He also hopes to enroll people in clinical trials to ensure they have access to the therapy.
He said, "But there are very few options."
Novartis stated that it can supply more Pluvicto if the FDA approves the Milburn plant in New Jersey.
CNN was informed by the agency that it was unable to provide details about any communications or actions with companies based on commercial confidential information.
To be clear, the FDA doesn't manufacture, package, ship, or bottle drugs. It cannot forbid companies from doing so. The FDA will work with companies that make drugs in short supply to increase production, if they are willing. They may need to approve new production lines or new raw material sources in order to increase their supply. FDA can expedite the review to resolve shortages of essential drugs.
Novartis also plans to build a plant in Indianapolis, where the drug will eventually be manufactured, but it won't be operational until the end of this year, according to the company.
Doctors will often tell patients that they won't be in a position to give them the life-extending drug until then.
Spratt said that some men and their doctors will feel like they have lost hope. Spratt said, "Cancer is not the enemy here. But it's unfortunate that you will have that excitement that your doctor will be able prescribe it to me and not be able give it to me."