A new drug regimen for certain types of pancreatic cancer recently received approval from the U.S. Food and Drug Administration (FDA) — the first new medication in nearly a decade.

Onivyde (irinotecan liposome), an injectable medication made by Ipsen, has been approved for use along with oxaliplatin, fluorouracil and leucovorin as a regimen for patients with metastatic pancreatic adenocarcinoma (mPDAC).

This type of cancer is an aggressive malignancy with an average life expectancy of between eight and 11 months, according to the National Institutes of Health (NIH).

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The approval was based on a randomized, controlled trial that included 770 patients with metastatic pancreatic adenocarcinoma who had not previously received chemotherapy, according to an FDA press release.

The group of patients who received the new regimen via IV infusion showed “significant improvements” in survival rates and response rates compared to the control group.

The drug regimen is administered via IV for 90-minute sessions every two weeks.

“I am hopeful that this regimen represents a new reference — meaning we will add to this in the future,” Dr. Zev Wainberg, professor of medicine and co-director of the UCLA GI Oncology Program in Los Angeles, told Fox News Digital.

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“We needed clarity on the data before proceeding, which the Phase 3 trial provides.”

Metastatic pancreatic cancer is one of the most difficult cancers to treat, Wainberg noted, as it doesn’t respond as well to new drugs that work in other types of the disease. 

“Patients are unfortunately often quite sick, and many cancers move too fast for a drug to work as they might in other cancers,” he noted.

Metastatic pancreatic cancer is one of the most difficult cancers to treat, a doctor noted, as it doesn’t respond as well to new drugs that work in other types of the disease.  (iStock)

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, said the drug is “a useful new tool, but not a game-changer.”

“It works well in conjunction with other chemotherapies that have been used for widespread pancreatic cancer,” Siegel told Fox News Digital. 

“It works by interfering with DNA replication in the cancer and by damaging the tumor’s DNA repair.”

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Dr. Peter Hosein, M.D., associate director of clinical research at the University of Miami’s Sylvester Comprehensive Cancer Center’s Pancreatic Cancer Research Institute, also commented on the new approval.

“Pancreatic cancer is a deadly disease where meaningful progress is sorely needed in prevention, early detection and treatment to improve outcomes,” he told Fox News Digital.

The group of patients who received the new regimen via IV infusion showed “significant improvements” in survival rates and response rates compared to the control group. (iStock)

Onivyde is a new formulation of an old drug that is “almost identical,” Hosein said.

“So, although this is a new approval, it does not really represent meaningful progress,” he told Fox News Digital. 

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Onivyde is also “substantially more expensive” than Irinotecan, the existing standard medication, Hosein pointed out. 

“There are many doctors and scientists working around the clock on this disease and the survival rates are slowly improving,” he said. 

“We need to continue focusing on breakthrough therapies that will truly move the needle to help our patients.” 

“There are many doctors and scientists working around the clock on this disease and the survival rates are slowly improving,” a doctor said of pancreatic cancer. (iStock)

The most commonly reported side effects of Onivyde are diarrhea, nausea, vomiting, fatigue, decreased appetite, abdominal pain, mucosal inflammation, constipation and weight loss, the FDA stated. 

“All drugs have a safety profile that needs to be taken seriously,” Wainberg said. 

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“Here, most of the combination produced GI upset — diarrhea and sometimes dehydration — so prophylactic (preventative) management is critical.”

Fox News Digital reached out to Ipsen, a French biopharmaceutical company headquartered in Paris, France, for additional comment.

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Princess Kate Middleton announced on Friday that she’s been diagnosed with cancer following major abdominal surgery in January.

The Princess of Wales has just begun a treatment regimen of “preventative chemotherapy,” she said in a video message.

After Middleton underwent “major abdominal surgery” in January, it was initially thought that her condition was “non-cancerous,” she said in the video message.

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However, later testing revealed that “cancer had been present.” 

She did not specify what type of cancer was diagnosed.

What is preventative chemotherapy?

Preventative chemotherapy, otherwise known as chemoprevention, is the use of certain drugs to help lower the risk of developing cancer or prevent it from returning, according to the NIH National Cancer Institute (NCI).

These include drugs like tamoxifen and raloxifene, which can be used in the prevention of “certain types of breast cancer in women who are at high risk of developing the disease,” the NCI said.

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Dr. Christina Annunziata, senior vice president of extramural discovery science at the American Cancer Society in Virginia, said that preventative chemo is given when the cancer has been removed, but there might be a few “microscopic cells” still remaining.

“There may be a few cells that have already spread and have the ability to regrow the cancer, and this is the purpose of the chemo to be given in this setting,” she told Fox News Digital. “The chemo is given to kill these cells and ‘prevent’ the cancer from relapsing or coming back.”

Another term for this treatment is “adjuvant chemotherapy,'” she said.

The American Society of Clinical Oncology (ASCO) website states that a doctor will use chemoprevention methods in cases where patients are high risk due to family history or a previous cancer diagnosis. 

Chemoprevention can involve medicines, vitamins or other substances dependent on cancer type, according to City of Hope.

Prince William and Princess Kate Middleton in a recent photo. The princess on Friday asked for privacy as she focuses on her treatment and recovery. (Getty Images)

These drugs are not used to treat cancer — and taking them “does not fully protect a person from developing cancer in the future,” noted ASCO.

Some of the more common side effects of chemotherapy include hair loss, fatigue, nausea, vomiting, easy bruising and bleeding, appetite changes, weight changes, anemia and gastrointestinal issues.

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The princess on Friday asked for privacy as she focuses on treatment and recovery.

“We hope that you will understand that, as a family, we now need some time, space and privacy while I complete my treatment,” she said. 

“We hope that you will understand that, as a family, we now need some time, space and privacy while I complete my treatment,” Middleton said in her announcement on Friday. (Max Mumby/Getty Images)

“I am well and getting stronger every day by focusing on the things that will help me heal, in my mind, body and spirits.”

The princess noted that she looks forward to returning to work, but that she now “must focus on making a full recovery.”

“At this time, I am also thinking of all those whose lives have been affected by cancer,” she added. 

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“For everyone facing this disease, in whatever form, please do not lose faith or hope. You are not alone.”

Fox News Digital’s Lauryn Overhultz contributed to this report.

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• Fertility rates are projected to drop below sustainable levels globally by the end of the century, according to a new study.
• This trend is expected to create a divide between “baby boom” and “baby bust” regions, with low-income countries experiencing the boom.
• The study predicts that by 2050, more than half of countries will have fertility rates below replacement levels.

Fertility rates in nearly all countries will be too low to sustain population levels by the end of the century, and most of the world’s live births will be occurring in poorer countries, according to a study published on Wednesday.

The trend will lead to a “baby boom” and “baby bust” divide across the world, with the boom concentrated in low-income countries that are more susceptible to economic and political instability, senior researcher Stein Emil Vollset from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington in Seattle said in a statement.

The study reported in The Lancet projects 155 of 204 countries and territories worldwide, or 76%, will have fertility rates below population replacement levels by 2050. By 2100, that is expected to rise to 198, or 97%, researchers estimated.

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The forecasts are based on surveys, censuses, and other sources of data collected from 1950 through 2021 as part of the Global Burden of Diseases, Injuries, and Risk Factors Study.

Over three-quarters of live births will occur in low- and lower-middle-income countries by the end of the century, with more than half taking place in sub-Saharan Africa, researchers said.

The global fertility rate – the average number of births per woman – has fallen from around 5 children in 1950 to 2.2 in 2021, data show.

By 2021, 110 countries and territories (54%) had rates below the population replacement level of 2.1 children per woman.

The study highlights a particularly worrying trend for countries like South Korea and Serbia, where the fertility rate is less than 1.1 child per female, exposing them to challenges of a dwindling workforce.

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Many of the most resource-limited countries “will be grappling with how to support the youngest, fastest-growing population on the planet in some of the most politically and economically unstable, heat-stressed, and health system-strained places on earth,” Vollset said.

While tumbling fertility rates in high-income countries reflect more opportunities for education and employment for women, researchers said the trend signals an urgent need for improvement in access to modern contraception and female education in other regions.

In addition, “once nearly every country’s population is shrinking, reliance on open immigration will become necessary to sustain economic growth,” IHME’s Natalia Bhattacharjee, a coauthor of the report, said in a statement.

The authors noted that predictions were limited by quantity and quality of past data, especially for the 2020 to 2021 COVID-19 pandemic period.

Many thousands of prostate cancer cases were missed during the disruption of the COVID pandemic.

Those are the findings of a new study published in BJU International last month.

Researchers from the University of Oxford and other U.K. universities analyzed a dataset of 285,160 participants from OpenSAFELY-TPP, a large, nationally representative dataset of routine health care records.

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They focused on 165,410 men in the U.K. who had been diagnosed with prostate cancer between Jan. 2015 and July 2023.

In 2020, diagnoses of prostate cancer dropped by 31% over the prior year.

The decrease was 18% in 2021. 

By 2022, the diagnosed cases had returned to expected levels.

“Given that our dataset represents 40% of the population, we estimate that proportionally the pandemic led to 20,000 missed prostate cancer diagnoses in England alone,” the researchers wrote in the study discussion. 

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During that time, the age at the time of diagnosis shifted to older individuals.

“The increase in incidence recorded in 2023 was not enough to account for the missed cases,” the researchers also stated — which means the diagnoses have not yet “caught up” to those that flew under the radar in 2020 and 2021.

Based on these findings, the researchers are recommending that health care providers focus on finding the men who were affected. 

Diagnoses of prostate cancer in 2020 dropped by 31% over the prior year, a new study has revealed. (iStock)

“More research is needed to investigate the consequences of this on patients and health care systems,” they noted.

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, pointed out that there is no universal screening program in the U.K. for prostate cancer.

“That’s because the feeling is that the PSA [prostate-specific antigen] may be inaccurate,” said Siegel, who was not involved in the new U.K. study. 

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“I disagree with that, because most of us here in the U.S. (primary care docs and urologists) follow trends in the PSA, knowing it isn’t perfect but using it as a guide to something going on in the prostate.”

The PSA is a blood test that measures the level of a specific protein that is made by the prostate.

There is no universal screening program in the U.K. for prostate cancer, Dr. Marc Siegel of New York City noted. (iStock)

“In the U.K., there is currently a massive ongoing study on the effectiveness of different kinds of screening modalities for prostate cancer, but in the U.S., many major medical centers — including mine — have already integrated the latest MRI tests to look at patients with high PSA or increasing trends prior to prostate biopsy,” Siegel told Fox News Digital.

“The delayed diagnoses in the U.K. are not surprising.” 

“The MRI also allows you to target the biopsy to a certain area of abnormality when needed.”

Regarding the effects of the pandemic, Siegel noted that lockdowns led to a delay in routine medical care both in the U.S. and in the U.K.

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“The delayed diagnoses in the U.K. are not surprising,” he added.

The study did have some limitations, the researchers acknowledged.

First, it focused only on data from England — so it does not apply to global populations.

Based on the new findings, the researchers recommend that health care providers focus on finding the men who were affected.  (iStock)

It is also possible that some cases were missed, as the diagnoses were pulled from primary care health records rather than cancer registries.

“However, in the U.K., the information about cancer diagnosis is sent to primary care within the hospital discharge letters and primary care is a valid source of these data,” the researchers stated.

“We validated the results against other published studies, and they closely align, confirming the validity of the methodology.”

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The study doesn’t prove that COVID caused the dip in diagnoses, the researchers noted — as it’s possible there are “multiple explanatory factors not limited to the COVID-19 pandemic.”

But the study did note that “during the COVID-19 pandemic, the resources, and the attention in healthcare systems globally, shifted toward preventing and managing COVID-19. Access to the non-COVID-19-related healthcare services changed, waiting times increased, and cancer pathways including treatment standards were adapted.”

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It also said, in part, that “patients’ healthcare-seeking behavior changed as people adopted social distancing (limiting face-to-face contact) and shielding (safeguarding high-risk people) to protect themselves and others from an infection.”

Fox News Digital reached out to the study authors for additional comment.

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