FDA panel backs new cancer treatment

FDA advisers back Novartis' game-changing personalized CAR-T for cancer, approval in sight

FDA advisers back Novartis' game-changing personalized CAR-T for cancer, approval in sight

When a patient is treated under the Novartis process, T cells are extracted from a patient's blood, frozen and sent to the company's plant in Morris Plains, N.J. There, the cells are genetically modified to attack the cancer, expanded in number, refrozen and shipped back to the patient for infusion. It's approved for children and young adults between the ages 3 and 25, the Times said.

Treatment with a single dose of the resulting product had produced long remissions, and possibly cures, in scores of patients in studies who were facing death due to the failure of every other treatment.

Explaining their vote, many advisors were effusive.

A new cancer treatment endorsed Wednesday by the Federal Drug Administration's Oncologic Drugs Advisory Committee is being described by one panel member as "the most exciting thing I've seen in my lifetime".

Slightly fewer patients experienced neurological side effects, such as seizures and hallucinations, according to the committee's briefing document.

Novartis said the entire process will take 22 days by the time it is launched.

Nothing was helping until an experimental therapy called CAR-T.

The FDA is also reviewing a CAR-T from Kite Pharma for the treatment of adults with advanced and aggressive lymphoma. "You have to be a long-term survivor to experience [long-term] toxicity", said Bruce Roth of the Washington University School of Medicine in St. Louis, MO. "If your child is in that 10 to 20 percent, you are desperate", Dr. Nichols said, while cautioning that it is too early to tell whether CAR-Ts offer lasting remissions for patients.

The therapy from Novartis would not be used broadly.

In 2014, U.S. regulators designated CTL019 as a "breakthrough therapy" and put the experimental immunotherapy agent on the fast track to market approval, after 89 percent of leukemia patients in early trials saw their cancers disappear.

Police seeking gunman in triple homicide near Birmingham
Authorities searched for an armed man Wednesday following a shooting at an Alabama mobile home community near Birmingham. According to the department, a protection from abuse order was issued against Lever in Jefferson County just past year .

"In those settings, the downstream effect [of triggering a secondary cancer] is conceivable", said Maziarz.

Shares of Novartis closed up 1.5% in Wednesday trading.

The University of Pennsylvania (Penn) has first developed CTL019, which uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular responses. In a briefing document to the ODAC, FDA staffers cautioned that a major consideration for manufacturing CTL019 was the need for "a well-controlled manufacturing process that can consistently produce high-quality vehicle T cells that are safe, pure, and potent".

In 2012, she was dying from one of the most common forms of leukemia called ALL.

But CAR-T's potential goes far beyond leukemia. Penn has a next-generation CAR-T under development, dubbed CTL-119, which is not licensed to Novartis.

The CAR T-cell treatment, manufactured by the drug company Novartis, initially would be available only for the small number of children and young adults whose leukemia does not respond to standard care.

Such a complex system for making personalized treatments is likely to drive up their cost, and the next big hurdle (assuming an FDA approval this fall) is to win over insurers.

The cells are grown in culture before they are reintroduced into the patient.

Vehicle T-cell therapy, made by Novartis, retrains a patient's immune cells so they target and attack cancer; the cells are removed from the body, sent to Novartis' plant so they can be genetically modified, and then shipped back to the patient for infusion.

Recommended News

  • President sued over 'unconstitutional' blocking on Twitter

    President sued over 'unconstitutional' blocking on Twitter

    President Donald Trump is being sued by a group of seven Twitter users after he blocked them on the popular social media app. The writer regularly and publicly criticizes Trump on social media, but on June 13 he discovered that he was blocked .
    Facebook Messenger Ads Are Going Global

    Facebook Messenger Ads Are Going Global

    It's worth noting that the betas Facebook performed in Thailand and Australia involved sending almost all Messenger users ads. The chat app admits it is rolling out ads for all users in an effort to boost revenue, after conducting initial tests.
    Takata Recalling Another 2.7 Million Faulty Airbags

    Takata Recalling Another 2.7 Million Faulty Airbags

    The company said it did not know what repairs were being attempted, but said the ignition switch was in the "on" position. The individual working on the vehicle in Florida died a day after sustaining injuries when the air bag deployed.
  • Bipartisanship is best answer to addressing health care

    Bipartisanship is best answer to addressing health care

    Democrats call the Republican legislation a giveaway to the rich that would hurt millions of the most vulnerable Americans. Cruz's amendment has drawn support from conservative senators and groups, who say the amendment will help lower premiums.
    Beachgoers form human chain to rescue family caught in riptide

    Beachgoers form human chain to rescue family caught in riptide

    Still, they ventured into the surf to help save the exhausted swimmers, who had been treading water for at least 20 minutes. Thanks to a beach full of Good Samaritans, ten lives were saved from a rip current at Panama City Beach in Florida .
    Wimbledon defends shunting women from centre court

    Wimbledon defends shunting women from centre court

    Muguruza won the French Open previous year , but followed up her first major title by losing in the second round at Wimbledon . In the last five matches of Adrian Mannarino , he has won four matches and lost one match in Antalya against Yuichi Sugita.
  • Best Tweets By Indian Cricketers Congratulating Mithali Raj For Her Record

    Best Tweets By Indian Cricketers Congratulating Mithali Raj For Her Record

    Mithali, however, was very slow off the blocks even though her innings had four boundaries and a six. Her unbeaten 76 saw her pass 5000 career runs but she fell just one run short of 3000 ODI runs.
    American to end Etihad & Qatar codeshares over subsidy row

    American to end Etihad & Qatar codeshares over subsidy row

    Qatar Airways chief executive officer Akbar Al Baker apologised for calling all American flight attendants "grandmothers". Etihad accused American for being anti competitive and anti consumer and was very disappointed with this decision.
    New organ donors sought as record numbers saved in Suffolk and Essex

    New organ donors sought as record numbers saved in Suffolk and Essex

    The latter only applies to donating a kidney, a small part of your liver, bone from a hip or knee replacement or your placenta. More than 200 people are now alive in Northumberland thanks to organ donation, according to new figures released today.
  • Wimbledon 2017: Venus Williams to ask Serena for advice on Garbine Muguruza

    Wimbledon 2017: Venus Williams to ask Serena for advice on Garbine Muguruza

    At the Australian Open a year ago , Konta reached her only pervious major semifinal, beating Williams in the first round. Muguruza , who was born in Venezuela and raised in Spain, cruised in her semifinal, 6-1, 6-1 over Magdalena Rybarikova .
    Sixteen die in US military plane crash in Mississippi

    Sixteen die in US military plane crash in Mississippi

    County emergency management director Fred Randle said there were no survivors from the plane, according to CNN. Julian Keviann, 31, was killed Monday night when the military aircraft went down in a field Monday night.
    IPhone production issues reportedly threaten Apple sales rebound

    IPhone production issues reportedly threaten Apple sales rebound

    But even though the hardware modules needed for the feature to work are good to go, the software reportedly isn't up to par yet. Whatever shape the iPhone 8 launches in you shouldn't have too long to wait for it, with a September or October launch likely.

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.