CSN’s Jayvian Tanelus and offensive line erupt in round oneCape Coral family opens home up for the holidays
NAPLES CSN’s Jayvian Tanelus and offensive line erupt in round one Community School of Naples’ offensive line and Jayvian Tanelus put on a show in round one of the playoffs earning them player of the week.
CAPE CORAL Cape Coral family opens home up for the holidays A Cape Coral family has gotten over 1,000 interactions on a Facebook post after opening up their home for the holidays.
SANIBEL Sanibel police trained and certified to catch alligators by FWC Pinning an apex predator down with little more than bare hands and tape: That’s what the Sanibel Police Department went through during alligator-catching certification training.
Southwest Florida welcomes first proton beam therapy center This is a big week in cancer care for patients in Southwest Florida and beyond.
PUNTA GORDA Whats next after Punta Gorda city manager’s resignation? Punta Gorda city manager Greg Murray said he resigned Monday but told the council on Wednesday. Now, Melissa Reichert is the interim city manager.
FORT MYERS BEACH 34th annual American Sand Sculpting Championship begins on Fort Myers Beach After a years long wait, the American Sand Sculpting Competition on Fort Myers Beach returned on Thursday.
CAPE CORAL City council members talk about decision to repeal stipend ordinance A vote of 5 to 3 ends the saga over the Cape Coral City Council stipend and new members of the city council are sending a message they’re doing things differently.
FORT MYERS Fort Myers food pantry provides Thanksgiving meals to neighbors Dozens of people stopped by Sunshine Health’s food pantry one week before Thanksgiving. Sunshine Health is delivering hope.
FORT MYERS BEACH Fort Myers Beach loses FEMA insurance discount The National Flood Insurance Program (NFIP) has placed Fort Myers Beach (FMB) on probation.
FORT MYERS WINK News Game of the Week: Riverdale at Fort Myers Our WINK News Game of the Week is the regional semifinal matchup between Fort Myers and Riverdale, a rematch from the regular season finale two weeks ago.
NAPLES Hope for the Holidays turkey distribution event in Collier County A Naples nonprofit is expected to feed nearly 2,000 families.
Parts of Lee County to keep FEMA discount According to the Lee County Government, residents in parts of Lee County will keep their FEMA discount.
New blue-light system to be implemented to flag red-light runners Green means go, red means stop and blue means you just ran a red light.
New Punta Gorda City Council accepts city manager’s resignation Punta Gorda’s new City Council accepted City Manager Greg Murray’s resignation Nov. 20 and agreed to pay toward hurricane repairs and provide several months of rent abatement to business owners who lease space at city-owned Herald Court. Debi Lux was named mayor and Greg Julian vice mayor by the new-look Council, which saw three incumbents […]
Vehicle catches on fire after crash at intersection of Alico and Oriole Rd. A vehicle caught on fire after a crash at the intersection of Alico Rd. and Oriole.
NAPLES CSN’s Jayvian Tanelus and offensive line erupt in round one Community School of Naples’ offensive line and Jayvian Tanelus put on a show in round one of the playoffs earning them player of the week.
CAPE CORAL Cape Coral family opens home up for the holidays A Cape Coral family has gotten over 1,000 interactions on a Facebook post after opening up their home for the holidays.
SANIBEL Sanibel police trained and certified to catch alligators by FWC Pinning an apex predator down with little more than bare hands and tape: That’s what the Sanibel Police Department went through during alligator-catching certification training.
Southwest Florida welcomes first proton beam therapy center This is a big week in cancer care for patients in Southwest Florida and beyond.
PUNTA GORDA Whats next after Punta Gorda city manager’s resignation? Punta Gorda city manager Greg Murray said he resigned Monday but told the council on Wednesday. Now, Melissa Reichert is the interim city manager.
FORT MYERS BEACH 34th annual American Sand Sculpting Championship begins on Fort Myers Beach After a years long wait, the American Sand Sculpting Competition on Fort Myers Beach returned on Thursday.
CAPE CORAL City council members talk about decision to repeal stipend ordinance A vote of 5 to 3 ends the saga over the Cape Coral City Council stipend and new members of the city council are sending a message they’re doing things differently.
FORT MYERS Fort Myers food pantry provides Thanksgiving meals to neighbors Dozens of people stopped by Sunshine Health’s food pantry one week before Thanksgiving. Sunshine Health is delivering hope.
FORT MYERS BEACH Fort Myers Beach loses FEMA insurance discount The National Flood Insurance Program (NFIP) has placed Fort Myers Beach (FMB) on probation.
FORT MYERS WINK News Game of the Week: Riverdale at Fort Myers Our WINK News Game of the Week is the regional semifinal matchup between Fort Myers and Riverdale, a rematch from the regular season finale two weeks ago.
NAPLES Hope for the Holidays turkey distribution event in Collier County A Naples nonprofit is expected to feed nearly 2,000 families.
Parts of Lee County to keep FEMA discount According to the Lee County Government, residents in parts of Lee County will keep their FEMA discount.
New blue-light system to be implemented to flag red-light runners Green means go, red means stop and blue means you just ran a red light.
New Punta Gorda City Council accepts city manager’s resignation Punta Gorda’s new City Council accepted City Manager Greg Murray’s resignation Nov. 20 and agreed to pay toward hurricane repairs and provide several months of rent abatement to business owners who lease space at city-owned Herald Court. Debi Lux was named mayor and Greg Julian vice mayor by the new-look Council, which saw three incumbents […]
Vehicle catches on fire after crash at intersection of Alico and Oriole Rd. A vehicle caught on fire after a crash at the intersection of Alico Rd. and Oriole.
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.