NORTH FORT MYERS LCSO searching for missing endangered adult Lee County Sheriff’s Office is investigating a missing person.
The Weather Authority: Scattered storms for your Saturday The Weather Authority is tracking afternoon scattered storms for Saturday this Labor Day weekend.
WINK NEWS SWFL Scoreboard: High School Football Week 2 The Golden Eagles took down the Cougars 64-7 to win the Crosstown Showdown for the 26th year in a row.
NAPLES Naples mayor speaks out after DUI arrest Naples Mayor Teresa Heitmann has sent a statement to WINK News after being charged with a DUI.
FORT MYERS Woman stabbed at Fort Myers gas station Authorities responded to an active scene at a 7-eleven in Fort Myers after a woman was stabbed early Friday evening.
FORT MYERS FMPD investigating a van that followed a student from bus stop Police said a suspicious van followed a middle school student home from the bus stop on Thursday and yelled, “Get in the van.”
CAPE CORAL Report: Teen was on crosswalk when she was hit The driver of the box truck told officers he didn’t see Kendra as she rode in front of him, and he started to go.
FORT MYERS BEACH Celebration of Jimmy Buffet Day at Margaritaville Friday was Jimmy Buffett Day at Margaritaville and Fort Myers Beach is gearing up for a fun party all weekend long.
PUNTA GORDA Charlotte County deputies hold training for mental health encounters Charlotte County deputies are entering the community equipped with a new tool for handling mental health: the crisis initiative training.
Neighbors worried about flooding in Rotonda Heights Neighbors in Rotonda Heights are fed up with the flooding and they want to see it fixed.
ORLANDO Smart living moms reclaim their careers Betsy Gardner president and CEO of the Winter Park Chamber of Commerce started Relaunch, a program to help stay-at-home moms.
FORT MYERS BEACH A closer look at the gas leak that killed 2 men at Fort Myers Beach home A closer look at the gas leak that killed two men in Fort Myers Beach has revealed some new details leading up to the deaths.
SANIBEL Sanibel CVS Pharmacy reopening after Hurricane Ian The CVS Pharmacy in Sanibel is reopening nearly two years after Hurricane Ian caused severe damage to it.
FORT MYERS Woman transported after boat hits large wake under Midpoint Bridge A woman had to be transported to the hospital after suffering an injury when the boat she was in struck the wake of a yacht.
NEW YORK (AP) Trump has history sparking outrage for incidents around veterans even as military voters backed him The reported altercation at Arlington National Cemetery involving Donald Trump’s staff was far from the first time that veterans or the families of service members have criticized the former president for words or behavior they saw as disparaging.
NORTH FORT MYERS LCSO searching for missing endangered adult Lee County Sheriff’s Office is investigating a missing person.
The Weather Authority: Scattered storms for your Saturday The Weather Authority is tracking afternoon scattered storms for Saturday this Labor Day weekend.
WINK NEWS SWFL Scoreboard: High School Football Week 2 The Golden Eagles took down the Cougars 64-7 to win the Crosstown Showdown for the 26th year in a row.
NAPLES Naples mayor speaks out after DUI arrest Naples Mayor Teresa Heitmann has sent a statement to WINK News after being charged with a DUI.
FORT MYERS Woman stabbed at Fort Myers gas station Authorities responded to an active scene at a 7-eleven in Fort Myers after a woman was stabbed early Friday evening.
FORT MYERS FMPD investigating a van that followed a student from bus stop Police said a suspicious van followed a middle school student home from the bus stop on Thursday and yelled, “Get in the van.”
CAPE CORAL Report: Teen was on crosswalk when she was hit The driver of the box truck told officers he didn’t see Kendra as she rode in front of him, and he started to go.
FORT MYERS BEACH Celebration of Jimmy Buffet Day at Margaritaville Friday was Jimmy Buffett Day at Margaritaville and Fort Myers Beach is gearing up for a fun party all weekend long.
PUNTA GORDA Charlotte County deputies hold training for mental health encounters Charlotte County deputies are entering the community equipped with a new tool for handling mental health: the crisis initiative training.
Neighbors worried about flooding in Rotonda Heights Neighbors in Rotonda Heights are fed up with the flooding and they want to see it fixed.
ORLANDO Smart living moms reclaim their careers Betsy Gardner president and CEO of the Winter Park Chamber of Commerce started Relaunch, a program to help stay-at-home moms.
FORT MYERS BEACH A closer look at the gas leak that killed 2 men at Fort Myers Beach home A closer look at the gas leak that killed two men in Fort Myers Beach has revealed some new details leading up to the deaths.
SANIBEL Sanibel CVS Pharmacy reopening after Hurricane Ian The CVS Pharmacy in Sanibel is reopening nearly two years after Hurricane Ian caused severe damage to it.
FORT MYERS Woman transported after boat hits large wake under Midpoint Bridge A woman had to be transported to the hospital after suffering an injury when the boat she was in struck the wake of a yacht.
NEW YORK (AP) Trump has history sparking outrage for incidents around veterans even as military voters backed him The reported altercation at Arlington National Cemetery involving Donald Trump’s staff was far from the first time that veterans or the families of service members have criticized the former president for words or behavior they saw as disparaging.
FILE – A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. According to research published Sunday, April 7, 2024, in the Journal of the American Medical Association, most cancer drugs granted accelerated approval by the FDA, meant to give patients early access to promising drugs, do not demonstrate such benefits within five years. (AP Photo/Manuel Balce Ceneta, File) The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives? In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. “Five years after the initial accelerated approval, you should have a definitive answer,” said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. “Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work or not.” The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval. Patients get access to drugs earlier, but the tradeoff means some of the medications don’t pan out. It’s up to the FDA or the drugmaker to withdraw disappointing drugs, and sometimes the FDA has decided that less definitive evidence is good enough for a full approval. The new study found that between 2013 and 2017, there were 46 cancer drugs granted accelerated approval. Of those, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials. The research was published in the Journal of the American Medical Association and discussed at the American Association for Cancer Research annual meeting in San Diego on Sunday. It’s unclear how much cancer patients understand about drugs with accelerated approval, said study co-author Dr. Edward Cliff of Harvard Medical School. “We raise the question: Is that uncertainty being conveyed to patients?” Cliff said. Drugs that got accelerated approval may be the only option for patients with rare or advanced cancers, said Dr. Jennifer Litton of MD Anderson Cancer Center in Houston, who was not involved in the study. It’s important for doctors to carefully explain the evidence, Litton said. “It might be shrinking of tumor. It might be how long the tumor stays stable,” Litton said. “You can provide the data you have, but you shouldn’t overpromise.” Congress recently updated the program, giving the FDA more authority and streamlining the process for withdrawing drugs when companies don’t meet their commitments. The changes allow the agency “to withdraw approval for a drug approved under accelerated approval, when appropriate, more quickly,” FDA spokesperson Cherie Duvall-Jones wrote in an email. The FDA can now require that a confirmatory trial be underway when it grants preliminary approval, which speeds up the process of verifying whether a drug works, she said.