FDA

Sept. 4 (UPI) — The Food and Drug Administration on Friday approved a new, targeted breast cancer drug for patients who become resistant to hormone therapy.

The drug, camizestrant, was approved under the FDA’s accelerated approval program.

It acts on ESR1 mutations, which are acquired resistances that tumors may develop during treatment for metastatic breast cancer.

“Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment,” acting FDA Commissioner Kyle Diamantas said in a statement. “We owe them every weapon in our arsenal.”

“Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”

Dr. Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said, “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval.”

“This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing,” he added.

“But additional evidence is needed to confirm clinical benefit.”

Sept. 3 (UPI) — The U.S. Food and Drug Administration on Thursday issued an Emergency Use Authorization for two drugs to prevent and treat New World screwworm, or NWS, in dogs and cats.

According to the agency, Capstar tablets and their generic version, nitenpyram, are approved for dogs, puppies, cats and kittens that are at least 4 weeks old and weigh at least 2 pounds.

Nitenpyram tablets were approved for treatment in June.

“Although the FDA has authorized or conditionally approved multiple products for the treatment of New World screwworm in dogs and cats, none were for prevention – until today,” Timothy Schell, director of the FDA’s Center for Veterinary Medicine, said. “The FDA is addressing a previously unmet need and giving pet owners and veterinarians important tools to protect dogs and cats from NWS infestations.”

The U.S. Department of Agriculture has confirmed 48 domestic cases of NWS in animals as of Thursday.

The FDA said most dogs and cats in the United States are at low risk of exposure to NWS because confirmed cases “are in a limited geographic region.” It said that dogs and cats that live, travel to, or return from areas where NWS have been identified, should be watched closely for signs of infestations.

Signs of infestations include visible maggots, foul odors in sounds or body openings. Veterinary care should be sought immediately for infested dogs and cats, the FDA said.

Capster is produced by Indianapolis-based Elanco Animal Health, while nitenpyram is made by Dublin-headquartered Felix Pharmaceuticals.

Aug. 27 (UPI) — The Food and Drug Administration on Thursday issued an emergency approval for the use of the drug ivermectin against New World screwworm infestations in cattle, adding to the arsenal of weapons available against the flesh-eating insect.

The FDA approved an Emergency Use Authorization, or EUA, for Bimectin, the generic version of ivermectin, for injections in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wounds, the agency announced.

Bimectin injection remains unauthorized for use in lactating dairy cows or in calves that will be processed for veal.

Thursday’s move is the 14th EUA issued by the FDA against New World screwworm as the Trump administration attempts to deal with the still-growing infestation in Texas.

The Department of Agriculture has confirmed 47 domestic cases of New World screwworm, or NWS, in animals as of Thursday.

NWS is widely feared as a serious health and economic threat that could cost billions of dollars in losses to cattle, bison and horses. The pest was eradicated from the United States in 1966 and eliminated as far south as Panama by 2000, but reemerged in 2022 and has continued moving north through Central America and Mexico.

The U.S.-Mexico border was closed last year to protect U.S. animals from the threat. The ban was subsequently lifted on July 26.

Texas Agriculture Commissioner Sid Miller last month urged the FDA to authorize ivermectin in feed as an additional tool to combat the growing NWS threat.

Injectable ivermectin is not enough to keep pace with the outbreak and protect livestock from further infestations, he asserted.

“Texas ranchers are fighting for their livelihoods and the security of the American food supply. They don’t have time to wait,” Miller said. “We’ve already seen this parasite spread across multiple Texas counties in just a few weeks. Every day we delay is another day the New World screwworm gains ground. We need every effective weapon available, and we need it now.”

The Texas Grain and Feed Association “has committed to rapidly manufacture and distribute medicated feed upon approval, ensuring producers can begin using it without delay,” he noted.

Aug. 26 (UPI) — On Wednesday, the U.S. Food and Drug Administration announced its approval of Rasonque, a new treatment option for people with advanced pancreatic cancer.

A tablet taken once a day, the medication targets forms of a protein called RAS, which is a key driver of tumor growth in many patients with pancreatic adenocarcinoma, the most common form of the cancer, the FDA said. This form of cancer develops in cells lining the ducts of the pancreas.

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer,” said Kyle Diamantas, acting commissioner of the FDA. “It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible.”

A press release from the FDA said the approval demonstrates the agency’s “commitment to moving with urgency, reducing unnecessary delays and advancing innovative treatments.”

Rasonque has been approved for adults who have metastatic pancreatic adenocarcinoma who have received at one least one prior systemic therapy or those who are not candidates for multiagent systemic therapy.

About 90% to 95% of the new cases of pancreatic cancer diagnosed in the United States each year are this form, the FDA said, citing the National Cancer Institute. Johns Hopkins Medicine also said “the vast majority” of pancreatic cancer diagnoses are this form.

In a clinical trial, the new treatment improved median overall survival to 13.2 months from 6.7 months with standard chemotherapy, the FDA said.

“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, director of the FDA’s Oncology Center of Excellence.

The agency granted this approval to Revolution Medicines Inc.

Aug. 25 (UPI) — On Tuesday, the U.S. Food and Drug Administration approved a device designed to continuously monitor both blood sugar levels and ketone levels in people with diabetes.

The Libre Duo 10-Day Continuous Dual Glucose Ketone Monitoring System is the first of its kind to be approved in the United States — both the first wearable device to monitor ketone levels and the first to combine monitoring of ketone and blood sugar levels, the FDA said. It’s approved for those ages 2 and older.

“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”

The U.S. Centers for Disease Control and Prevention estimates that 40.1 million Americans live with diabetes. About 2.1 million of them have type 1 diabetes, which also makes it important to monitor the levels of ketone, an acid. The body creates this substance when, due to a lack of insulin, it uses fat instead of glucose to produce energy. Too much ketone can cause diabetic ketoacidosis, a dangerous complication.

“Early detection of rising ketone levels is critical,” the FDA said.

Until now, the agency said, people had to monitor ketone levels with separate tests that only provided a single measurement at one point in time. The new system combines blood sugar and ketone tests and monitors them continuously. Readings — and alerts in case of dangerous trends — are sent wirelessly to a smartphone app.

The FDA previously granted “breakthrough device” status to the system, which is meant to expedite the device’s development and review.