Gilead Jumps After FDA Approves Its Kite-Acquired CAR-T Drug

A family in Massachusetts was hospitalized with carbon monoxide poisoning after they turned the heat on for the first time this season

A family in Massachusetts was hospitalized with carbon monoxide poisoning after they turned the heat on for the first time this season

That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. The FDA cautions that the drug is not indicated to treat patients with primary central nervous system lymphoma. Called immunotherapy, the patient's infection-fighting T-cells are extracted and genetically engineered with a new gene to pinpoint and kill the lymphoma cells.

Non-Hodgkin lymphomas account for roughly four percent of all cancers in the United States and an estimated 72,000 new cases are diagnosed each year, CNN said.

Yescarta is approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of conventional therapy.

The safety and efficacy of the novel gene therapy was investigated in a clinical trial that included more than 100 adults with refractory or relapsed DLBCL. These can include life-endangering neurologic toxicities - with symptoms of headache, limb numbness, loss of memory, vision, and/or intellect - and cytokine release syndrome, when a storm of immune proteins called cytokines are released into a patient's circulatory system.

Due to the complex nature of the procedure, a healthcare professional will have to go through training to be able to administer the pricey treatment - The Wall Street Journal says it will cost patients around $373,000.

Gilead's new approval is also for a broader patient population than the Novartis drug Kymriah.

"Gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer", FDA Commissioner, Scott Gottlieb, said in a statement.

General Motors to Pay Michigan Nearly $4 Million Following Settlement
The states alleged that some GM employees knew about the issue as early as 2004, but decided it was not a safety concern. The faulty ignition switches could move from the run position to the accessory or off position in certain conditions.

American regulators granted approval on Wednesday to a gene-altering treatment for patients suffering from lymphoma, the second-ever approval for a gene therapy procedure and one that could revolutionize how we fight cancer.

Gilead Sciences ( GILD ) jumped early Thursday after the Food and Drug Administration approved what is known as a CAR-T drug, dubbed Yescarta, to treat an aggressive form of non-Hodgkin lymphoma.

Because of these risks, the FDA has approved Yescarta with a risk evaluation and mitigation strategy (REMS), which includes a requirement that hospitals and clinics be specially certified before dispensing the therapy.

According to Gilead, about 7,500 lymphoma patients each year in the United States would be qualified for CAR-T treatment. "This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite's employees", Kite founder Dr. Arie Belldegrun said.

Similar CAR-T therapies are being developed by Juno Therapeutics Inc., Bluebird Bio Inc., and others.

Dr. Fred Locke, an oncologist and researcher at Moffitt Cancer Institute in Tampa, Florida, estimates that there are more than 10,000 adults who might benefit from these treatments, whereas the pediatric approval was initial geared for only about 600 patients a year.

Recommended News

  • Volkswagen Testing its Electric Car Mettle in the Mountains

    Volkswagen Testing its Electric Car Mettle in the Mountains

    Frank Welsch, development board member, says the challenge of Pikes Peak will help VW develop electric technology that's up to the task.
    Minnesotans don't need new ID for a year

    Minnesotans don't need new ID for a year

    MVD will request another one year extension in 2018, and will continue to work with DHS to ensure full compliance with the law. ME is receiving a yearlong extension from enforcement of federal requirements for state driver's licenses and ID cards.
    Gord Downie of Tragically Hip dies at 53

    Gord Downie of Tragically Hip dies at 53

    Last night Gord quietly passed away with this beloved children and family close by . Fellow Canadians Seth Rogen and KD Lang also remembered Downie on Twitter.
  • Orionid Meteor Shower to Peak This Week

    Orionid Meteor Shower to Peak This Week

    People hoping to spot Uranus should look for a blue-green body, visible to the naked eye when looking to the southeastern sky. The Orionids happen when earth passes through the tail of Haley's comet that's been left behind from previous passes.
    For the first time, astronomers spot 'kilonova' collision of neutron stars

    For the first time, astronomers spot 'kilonova' collision of neutron stars

    Albert Einstein predicted the existence of gravitational waves way back in 1915 on the basis of his theory of general relativity . In a million years, the cloud will spread across the whole galaxy, seeding stars and their solar systems with heavy elements.
    Iran nuclear deal: Khamenei denounces Trump's 'rants and whoppers'

    Iran nuclear deal: Khamenei denounces Trump's 'rants and whoppers'

    Last week, Trump refused to formally certify that Iran was complying with the nuclear deal, defying both allies and adversaries. Pouyanne has said Total would withdraw from Iran if obliged by law.
  • Children, 5 and 7, stabbed to death in Colorado Springs

    Children, 5 and 7, stabbed to death in Colorado Springs

    Responding officers from Effingham County, Ill. said a white Ford SUV was fully engulfed in flames when they arrived. Murphy had several months of intensive care and enrolled at a Colorado community college, Kibler said.
    Rashford preys on Benfica keeper's error for Manchester United victor

    Rashford preys on Benfica keeper's error for Manchester United victor

    But defensively the three-time European champions have also been solid, conceding just six goals in 13 games in all competitions. Rashford limped off on 76 minutes though Mourinho is hopeful his knee injury is only minor.
    Giant Ford F-Series Truck Recall to Cost $267 Million

    Giant Ford F-Series Truck Recall to Cost $267 Million

    According to the recall from Ford , a frozen door latch or bent or kinked actuation in the affected trucks is causing the issue. In September, Ford sold 82,302 F-Series trucks, up 21.4 percent from a year earlier.
  • 1.2 million in Washington take cover in annual ShakeOut drill

    1.2 million in Washington take cover in annual ShakeOut drill

    Californians should be prepared to be self-sufficient for 72 hours following an quake or other major disaster, officials say. Survival kits - stocked with water, food and a radio, among other items - can be crucial after a major temblor.
    Coast Guard suspends search for missing worker after explosion

    Coast Guard suspends search for missing worker after explosion

    Kenner city officials said they believe the cleaning chemicals ignited and caused the explosion, but an investigation is ongoing. The platform is a storage and accumulation point for oil and gas from a number of wells, company spokesman Tim O'Leary said.
    University of Florida Braces for White Nationalist Thursday

    University of Florida Braces for White Nationalist Thursday

    To push back against Spencer's speech, Alligator will offer a free draft beer in exchange for two tickets to the event. The school estimates it will spend $600,000 on security for Spencer's planned speech Thursday.

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.