FDA Approves Yescarta, First CAR T-Cell Therapy for Lymphoma
FDA Approves Yescarta, First CAR T-Cell Therapy for Lymphoma
Gilead Sciences shares bolstered after FDA approval validates Kite Pharma merger
21 October, 2017, 00:45
"It takes our most powerful immune cells in the body known as T-cells and it reengineers them to fight the B-cells that are causing the cancer in the first place", he said, adding that the innovation also has implications for more cancers. There are approximately 72,000 new cases of National Hockey League diagnosed in the United States annually. 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.
The FDA said diffuse large B-cell lymphoma is the most common type of non-Hodgkin's Lymphona in adults and there are approximately 72,000 new cases of National Hockey League diagnosed in the United States each year.
This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.
Diffuse large B-cell lymphoma is the most common type of the disease in adults, with some 72,000 new patients diagnosed annually in the USA, according to the American Cancer Society, and some 20,000 will die from it this year.
Axi-cel was approved with a boxed warning regarding cytokine release syndrome (CRS), which occurred in 13% of patients in the ZUMA-1 trial.
Gilead, which recently acquired Kite Pharma, said the list price for Yescarta, which is to be administered just once to each patient, would be $373,000. Patients must be informed of these risks before receiving the therapy. "We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms".
"The approval of Yescarta brings this innovative class of CAR-T cell therapies to an additional group of cancer patients with few other options - those adults with certain types of lymphoma that have not responded to previous treatments", said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. Commissioner Scott Gottlieb announced alongside the approval that FDA will soon issue a comprehensive agency policy clarifying how FDA's expedited programs apply to gene therapy products. The FDA has linked a risk evaluation and mitigation strategy with the approval: hospitals and their associated clinics that dispense axicabtagene ciloleucel need to be specially certified. Also, patients must be informed of the potential serious side effects and of the importance of promptly returning to the treatment site if side effects develop. Arie Belldegrun, MD, FACS, Founder of Kite, said in a statement.
The treatment is based on CAR-T therapy, which was developed by Israeli researchers at the Weizmann Institute of Science and the Tel Aviv Sourasky Medical Center.
Similar CAR-T therapies are being developed by Juno Therapeutics Inc., Bluebird Bio Inc., and others.
People with advanced lymphoma now have another type of treatment to consider.
Axicabtagene ciloleucel (Yescarta) has been approved to treat adult patients with diffuse large B-cell lymphoma who have not responded to or who have relapsed after at least 2 other kinds of treatment. While this therapy may be groundbreaking, it comes with potentially lethal side effects.
Sally Ride and Mae Jemisons build features a launchpad and Space Shuttle Challenger with three removable rocket stages. LEGO was really shooting for the stars with these incredible sets that will be available for purchase on November 1st.
Unlike other smart tags which uses Bluetooth LE, Samsung Connect Tag uses narrowband network technology (NB-IoT, Cat.M1). The Connect Tag will be available in South Korea first before arriving in other locations over the coming months.
The "unprecedented crisis" that Kwon may be alluding to is the arrest of Lee Jae-yong, the de facto leader of the Samsung. Kwon was expected to take a bigger role after the arrest of scion and heir apparent of Samsung Group, Jay Y Lee.
The statement comes on the heels of heightened rhetoric between North Korea and the United States over the past several months. Mr Kim warned that tensions on the peninsula have "reached the touch-and-go point and a nuclear war may break out any moment".
Voting for the 68-seat Himachal Pradesh Assembly will take place on November 9 and the results will be declared on December 18. Union minister Jitender Singh said that Congress party was questioning the wisdom and prudence of the constitutional body.
But one central issue has yet to be discussed: the fate of Hamas' militant wing and cache of rockets and weapons. In an online posting later, Netanyahu warned that the deal would make "peace much harder to achieve".
Just attach your Joy-Cons to the Switch unit and head over to the Controller section of the System Settings menu. This feature supports the games "Legend of Zelda: Breath of the Wild", " Arms " and " Splatoon 2 ".
The pound was little changed by the inflation numbers as most investors have already priced in a likely November rate hike. Many economists still remained confident that Carney and co would still hike rates at their coming meeting.
Tillerson's tenure as secretary of state has been dogged by rumors about rifts with Trump over policy. Pressed repeatedly on the subject by Tapper on Sunday, Tillerson refused to budge.
Look up to see the Orionids meteor shower tonight
The meteors will burst in every direction imaginable, so it might not even be necessary for you to look for the constellation. The best bet is to find a secluded spot outdoors with clear skies, and minimal city lights, according to Space.com.
ZTE Axon M dual-screen foldable smartphone launched
For the stretched mode where both the screens act as one, the phone will run the tablet version of the app. But ZTE comes with a big surprise and silently introduced the new ZTE Axon M smartphone with dual screens.
Sensex climbs 211 pts on positive economic data points
The 30-scrip Sensitive Index (Sensex) was trading 122.17 points or 0.38 per cent higher during the afternoon trade. On this basis, the Sensex rose by 201 points to 32, 634, while the Nifty advanced 63 points to 10,200.
Israel to join USA in quitting Unesco
According to Foreign Policy , France's United Nations ambassador, François Delattre, hoped the USA would stay within UNESCO . The critical juncture François Delattre referred to may be the selection of UNESCO's new director-general.
Facebook now lets you order food without leaving Facebook
On Friday, the social networking site announced that you'll now be able to order food for pick up and delivery through Facebook . However, the company made no comment as to how long that option was live, or what percentage of users on Facebook had it to use.
Modi, Nitish To Share Dais For First Time After Patch-Up
Referring to Ganga, Modi said: "If there was no Ganga, I do not know what condition our land would have been in". This was PM Modi's first ever full-fledged tour of the state since joining the hands with Nitish Kumar-led JDU.