web
stats
Image: Pixabay / DarkoStojanovic

The Facts

  • Novartis Oncology, a healthcare company that develops cancer treatments, announced Wednesday that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee unanimously recommended approval of Novartis’s gene-altering leukemia therapy, CAR-T cell therapy.
    • CAR-T cell therapy’s premise is that a body’s T cells can be trained to “recognize and kill cancer.”
      • T cells are white blood cells that are “essential for human immunity.”
    • According to Novartis, the drug works by “reprogramming” a patient’s cells.

“During the treatment process, T cells are drawn from a patient’s blood and reprogrammed in the manufacturing facility to create T cells that are genetically coded to express a chimeric antigen receptor to recognize and fight cancer cells and other B-cells expressing a specific antigen.”

  • Bruno Strigini, CEO of Novartis, made a statement about the FDA’s recommendation:

“We’re very proud to be expanding new frontiers in cancer treatment by advancing immunocellular therapy for children and young adults with r/r B-cell ALL and other critically ill patients who have limited options. We look forward to working with the FDA as they complete their review.”

  • Novartis also tweeted about the recommendation:

  • The FDA noted that the long-term effects of the therapy remain unknown.
    • In a report on the therapy, the FDA stated that “most study subjects have not been followed for very long, thus limiting the ability to assess the risk of delayed events.”

The Context

  • The therapy was first developed at the Novartis-Penn Center for Advanced Cellular Therapeutics at the University of Pennsylvania.
  • According to the Leukemia and Lymphoma Society, “There are an estimated 363,794 people living with, or in remission from, leukemia in the US.”
  • Between 2009 to 2013, Leukemia was the fifth and sixth most common cause of cancer-related deaths in men and women, respectively, according to the Leukemia and Lymphoma Society. 24,500 people are expected to die from leukemia in 2017, according to the Society.


 

Reactions

  • Arie Belldegrun, CEO of KitePharma, a company which works on cancer immunotherapy, made a statement about Novartis, her “competitor.”

“I will be Novartis’ biggest cheerleader today.

Kite and Novartis have consistently been positioned as competitors, and I am amused by the horse-race metaphors that are used to frame the various companies developing CAR-T therapies. Today is not about business or competition. Today, we are not rivals. Today is about advancing an exciting technology that has the potential to transform cancer treatment.”

  • Juno Therapeutics, a company which also works on CAR-T cell therapy research, released a statement congratulating Novartis.

“Today is the beginning of a new era of medicine and brings new hope to the children and their families battling this terrible disease. We congratulate Novartis, researchers, physicians, and most importantly, patients, who have contributed to this important moment in CAR T cell development.”

Megan Evershed contributed to this report.

The Whim News Team
AUTHOR

The Whim News Desk

We'd rather be second and accurate than be first and wrong. The Whim News Desk is a dedicated team of researchers and investigators committed to presenting the news without bias. Follow us @TheWhimOnline for daily news coverage without the spin!

Related News

Read More With McCain’s Opposition, Latest Effort to Repeal and Replace Obamacare is Dead

The Whim News Desk , in News

Read More Trump Issues EO Targeting Trade with N. Korea; Regime Calls Sanctions “Futile”

The Whim News Desk , in World

Read More Japan Says Time for “Dialogue” with North Korea Is Over 

The Whim News Desk , in World

Send this to a friend