Novartis asks FDA to expand Kymriah’s use against blood cancer

The logical next step in the evolution of CAR-T has occurred. Novartis’ Kymriah has already been approved for leukemia, while Gilead’s (originally Kite’s) Yescarta has been approved for diffuse large B-cell lymphoma (DLBCL). Now Novartis has filed for approval of Kymriah for DLBCL as well:

http://www.reuters.com/article/us-novartis-kymriah/novartis-asks-fda-to-expand-kymriahs-use-against-blood-cancer-idUSKBN1D00QR

Advertisements

Request for Feedback: What would you like to find on this blog?

Dear Readers,

Thanks to references from Lympho Bob and the Facebook group CAR T-CELL Patients And Carers, this blog has recently received upwards of 20 visits per day.  However, we’ve noticed that most visitors are finding little content to actually “click through”.  Perhaps the coverage here is not relevant to the typical reader?

So we ask you to please do us a small favor… Just take a moment to leave a comment here detailing what brought you here, what you were hoping to find, and what you think should be here on this blog.  We certainly don’t want to waste anyone’s time with information they deem irrelevant or uninteresting, and we want this blog to be a useful resource for readers.  Your feedback would be most appreciated!

— Ben & Bill

CAR-T free webinar Oct. 3, a new CAR-T entrant, etc…

CAR-Therapy: A New Twist on Transplants (free webinar Oct. 3 from the Blood & Marrow Transplant Information Network)
https://cc.readytalk.com/registration/#/?meeting=tznu7utt3rd4&campaign=ucfkj70ay5x2


A long article (you must navigate across several pages) that covers the topic well…

CAR T-cell therapy approval huge step for oncology, but only ‘beginning of story’
https://www.healio.com/hematology-oncology/leukemia/news/print/hemonc-today/%7B33119631-5996-45cf-9be6-8e36466ded9e%7D/car-t-cell-therapy-approval-huge-step-for-oncology-but-only-beginning-of-story


CAR-T Cell Therapy Is Here To Stay
https://www.forbes.com/sites/sciencebiz/2017/07/19/car-t-cell-therapy-is-here-to-stay/#596a32d6e5d7


Autolus, a British startup that has made news for raising $$ for their new CAR-T trials in lymphoma and multiple myeloma:

UK start-up Autolus starts ‘living medicine’ cancer trials
https://www.ft.com/content/128ce89c-97b5-11e7-a652-cde3f882dd7b

Three CAR-T cell therapy studies announced from UK start-up Autolus – EPM Magazine
https://www.epmmagazine.com/news/three-car-t-cell-therapy-studies-announced-from-uk-start-up-/#.WcmNl8p67wk.twitter

British biotech joins race to find ‘living medicines’ for cancer after cash injection
http://www.telegraph.co.uk/business/2017/09/26/british-biotech-joins-race-find-living-medicines-cancer-cash/

‘Living medicine’ cancer therapy starts clinical trials – GOV.UK
https://www.gov.uk/government/news/living-medicine-cancer-therapy-starts-clinical-trials


Autologous CAR-T Cell Manufacturing: Current Standing and Future Directions | GEN
http://www.genengnews.com/gen-exclusives/autologous-car-t-cell-manufacturing-current-standing-and-future-directions/77900982


Unpacking what $475,000 means (Slide presentation from Memorial Sloan-Kettering that turned up in social media)
https://www.keionline.org/sites/default/files/CAR-T_Kaltenboeck.pdf


(7) CAR-T – Welcome to the Jungle! | LinkedIn
https://www.linkedin.com/pulse/car-t-welcome-jungle-victoria-last/


Why Fred Hutch’s chief is enlisting techies to defeat cancer by 2025 – GeekWire
https://www.geekwire.com/2017/fred-hutch-president-gary-gilliland-enlisting-techies-defeat-cancer-2025/

 

 

CAR-T: The road ahead (controlling costs, new products and innovations, etc.)

“The cost of the leukemia treatment, called Kymriah, is ‘dramatically higher’ than other such complex treatments, and the health-care system isn’t ready to pay for it, Steve Miller, chief medical officer at Express Scripts Holding Co., said Thursday in a blog post on his company’s website.”

Novartis’s $475,000 Price on Cancer Therapy Meets Resistance – Bloomberg
https://www.bloomberg.com/news/articles/2017-09-22/novartis-s-475-000-price-tag-on-cancer-drug-meets-resistance

P.S.  In the “it’s a small world” department, the two companies mentioned above are Novartis and Express Scripts.  As it happens, two companies I worked at a few years before being diagnosed with lymphoma were Medco (acquired by Express Scripts) and Sandoz (merged with Ciba-Geigy to become Novartis).


Somehow (Twitter?), I stumbled on this site, Prescription Drug Prices and More.  It seems to be run by a pharmacist named Bertram Drachtman.  I found these two recent posts interesting:

Off The Shelf Car-T and Gene Therapy – Prescription Drug Prices and More
https://morethoughtsonpharmacy.wordpress.com/2017/09/18/off-the-shelf-car-t-and-gene-therapy/amp/

Car-T Therapy. A “Miracle Cure For Cancer In Our Time”? – Prescription Drug Prices and More
https://morethoughtsonpharmacy.wordpress.com/2017/08/02/car-t-therapy-a-miracle-cure-for-cancer-in-our-time/


Why CAR-T Therapies Don’t Work for Everyone Yet | GEN
http://www.genengnews.com/gen-exclusives/why-car-t-therapies-dont-work-for-everyone-yet/77900981


The CAR-T landscape going forward…

Evolution Bioscience | The CAR-T Revolution: Gilead’s Acquisition of Kite Pharma & FDA Approval of Novartis’ Kymriah Signal Tipping Point for Promising Cancer Immunotherapies
http://evolution-bio.com/news-analysis/car-t-revolution-gilead-acquisition-kite-pharma-fda-approval-novartis-kymriah-signal-tipping-point-cancer-immunotherapy/

A New Model T on the Horizon?
http://www.cell.com/cell/pdf/S0092-8674(17)31060-7.pdf


 

A very technically detailed explanation of the ins-and-outs of CAR-T, posted on Quora, apparently from someone with a PhD in Cancer Immunotherapy.  A fascinating read…

Tirumalai Kamala’s answer to Why didn’t the anti-CD19 CAR-T immunotherapies from Novartis or Kite suffer from neurotoxicity adverse events as the ones from Juno did? – Quora
https://www.quora.com/Why-didnt-the-anti-CD19-CAR-T-immunotherapies-from-Novartis-or-Kite-suffer-from-neurotoxicity-adverse-events-as-the-ones-from-Juno-did/answer/Tirumalai-Kamala


A reminder that CAR-T therapies, while potentially curative, “carry unique, potentially lethal side effects…”

Researchers compose guidelines for handling CAR-T cell side effects
https://www.europeanpharmaceuticalreview.com/news/67168/guidelines-car-t-cell-side-effects/


…behind the scenes, there’s another race going on: the effort to develop efficient manufacturing for CAR-T therapeutics.

The Other CAR-T Race: Manufacturing – Bioprocess Technology Consultants
https://www.bptc.com/car-t-race-manufacturing/


The publication below from the Journal of the AMA (JAMA) made headlines recently in places like the New York Times and NPR, especially in light of Novartis’ recent pricing of their FDA-approved Kymriah CAR-T therapy at $475,000.  The crux of the issue seems to be how to fairly compensate for all the “sunk costs” of failed drugs, a topic I heard about often during my employment at Sandoz (which ironically is now Novartis).  It seems a bit like the argument made by record companies back in the ‘80’s to charge $17 per CD, to compensate for their investments in albums that didn’t sell in the millions. This will certainly remain a hot topic…

Cost of Developing a Single Cancer Drug | Clinical Pharmacy and Pharmacology | JAMA Internal Medicine | The JAMA Network
http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2653012


Stories on Juno Therapeutics, the other CAR-T competitor besides Novartis and Kite.  (My CAR-T therapy at MSK in July 2015 was in partnership with Juno)

“The Seattle biotech company lost the race to be first with an approved treatment using the revolutionary approach called CAR-T cell therapy. But it still aims to be the best in class…”

Juno Therapeutics ready for another round in war on cancer | The Seattle Times
http://www.seattletimes.com/business/technology/juno-therapeutics-ready-for-another-round-in-war-on-cancer/

On CAR-T’s Edge, Seattle Researchers Plot to Bypass Novartis Therapy | Xconomy
http://www.xconomy.com/national/2017/09/19/on-car-ts-edge-seattle-researchers-plot-to-bypass-novartis-therapy/#

Considering investing in CAR-T?

“Juno has nine different drugs being tested in eleven different trials, all of which tap into the recently-validated science of CAR-T therapies. The race for them is only apt to heat up as time marches on, with some observers suggesting the CAR-T therapy market could be worth $8.5 billion by 2028.”

Yes, Juno Therapeutics (JUNO) Just Became a Great CAR-T Trade
https://www.yahoo.com/amphtml/finance/news/yes-juno-therapeutics-juno-just-110937168.html

September 2017 news updates (updated 11:45am)

A great piece from the New England Journal of Medicine detailing how we got here.  (This has been all over the web.) …


Comprehensive coverage of CAR-T from the NIH:


Patient Death Won’t Slow Research on “Off-the-Shelf” Immune Cells to Treat Cancer – MIT Technology Review
https://www.technologyreview.com/s/608803/amid-setback-researchers-forge-ahead-with-off-the-shelf-immune-cells-to-treat-cancer/


A plethora of new cancer treatments is under development
There will be more cures, and they will be expensive
https://www.economist.com/news/technology-quarterly/21728781-there-will-be-more-cures-and-they-will-be-expensive-plethora-new-cancer-0


Kymriah and the CAR-T roller coaster – MedCity News
https://medcitynews.com/2017/09/kymriah-car-t-roller-coaster/


By Jamie Reno, a longtime fNHL survivor himself.  Jamie really covers it in this piece:


CAR T-cells: an exciting frontier in cancer therapy – The Lancet
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32395-4/fulltext


Click the “Download as PDF” for a free, informative CAR-T wall chart:


Stories about that $475,000 price tag for Novartis CAR-T (updated 11:45am):







    CAR-T in the Courts | GEN
    Patent Disputes Bring Immunotherapy Technology and Patent Review Process into Focus
    http://www.genengnews.com/gen-exclusives/car-t-in-the-courts/77900974


    T-Cell Pioneer Carl June Acknowledges Key Ingredient Wasn’t His – MIT Technology Review (March 2016)
    https://www.technologyreview.com/s/601027/t-cell-pioneer-carl-june-acknowledges-key-ingredient-wasnt-his/


    5 Significant Developments With CAR-T Therapy
    http://www.ajmc.com/newsroom/5-significant-developments-with-car-t-therapy


    CAR-T Mania: Could Juno Therapeutics Get Acquired Next? | Fox Business
    http://www.foxbusiness.com/markets/2017/09/10/car-t-mania-could-juno-therapeutics-get-acquired-next.html


    A CAR-T Conversation with Gregg Sando, CEO of Cell Medica
    The CAR-T Race is Far from Over: This CEO is Exploring a New Avenue
    https://labiotech.eu/cell-medica-gregg-sando-car-t/