Health Highlights: March 11, 2019
Import Alert on Genetically Engineered Salmon Lifted by FDA FDA Approves 1st Immunotherapy Drug for Breast Cancer Flu Season May Have Peaked: CDC
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Import Alert on Genetically Engineered Salmon Lifted by FDA
An import alert that prevented genetically engineered salmon from entering the United States has been lifted by the U.S. Food and Drug Administration.
In 2015, the FDA deemed the AquaAdvantage Salmon safe, marking the first U.S. approval of a genetically engineered animal intended for food, CNN reported.
But in 2016, Congress said the salmon could not be sold in the United States until the FDA finalized labeling guidelines to inform consumers the product was genetically engineered. That's when the FDA implemented the import alert, CNN reported.
Also in 2016, Congress passed a law directing the U.S. Department of Agriculture to set a national mandatory standard for disclosing bioengineered foods. That standard was issued last December.
FDA Commissioner Scott Gottlieb said because of the 2016 law and the USDA's new standard, the FDA "no longer has the authority to issue labeling guidance," CNN reported.
"However, the FDA believes this Congressional mandate has been satisfied by the USDA's issuance of final regulations implementing that law in late 2018 because the law and regulations require that human food containing GE [genetically engineered] salmon bear labeling indicating that it is bioengineered," Gottlieb said in a statement.
The FDA will now permit importation of AquaAdvantage Salmon eggs, produced by AquaBounty, to the company's facility in Indiana to be raised into salmon for food, CNN reported.
FDA Approves 1st Immunotherapy Drug for Breast Cancer
The U.S. Food and Drug Administration has given its blessing to the first immunotherapy regimen for breast cancer.
The combination of immunotherapy (Tecentriq) and chemotherapy (Abraxane) was given accelerated approval for triple-negative breast cancer that is locally advanced or has spread, cannot be surgically removed, and has cells that have a protein called PD-L1, CNN reported.
A study published last October in the New England Journal of Medicine found that median progression-free survival (length of time a patient's cancer does not worsen) was 7.4 months among patients who received the combination therapy, compared with 4.8 months among those who received chemotherapy with a placebo, the FDA said Friday.
The study was funded by Genentech Inc., the maker of Tecentriq.
"This is the first time immunotherapy has worked in such a difficult to treat cancer, and is a huge step forward for these breast cancer patients," study author Dr. Peter Schmid, from Queen Mary University of London, said in a statement last October, CNN reported.
The accelerated approval is just the start, noted Dr. Otis Brawley, professor of oncology and epidemiology at Johns Hopkins University.
"The FDA has approved it based on progression-free survival with the hope that later on ... data will show that the treatment actually makes women live longer," Brawley told CNN.
Flu Season May Have Peaked: CDC
It looks like the flu season has peaked in the United States, though there's been a recent rise in the number of cases involving a more severe flu strain.
Flu was widespread in 48 states last week, down from 49 the previous week, according to a U.S. Centers for Disease Control and Prevention update released Friday. CDC experts believe there's a 90 percent chance the flu season has peaked, the Associated Press reported.
Several flu strains often circulate in the United States at the same time, but one strain typically dominates.
A milder strain of flu has been the most common cause of cases this flu season. But over the last two weeks, about 60 percent of flu virus samples tested were a strain called Type A H3N2, which tends to cause more hospitalizations and deaths, especially in the elderly, the AP reported.
There have been 20,000 to 30,000 flu-related deaths in the United States so far this winter, about 300,000 flu-related hospitalizations, and around 25 million flu illnesses, according to the CDC.