trending Market Intelligence /marketintelligence/en/news-insights/trending/BPMzFljE_1zr_Ivk6jS6jQ2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

In This List

Gilead seeks US FDA approval for blood cancer therapy

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform


Gilead seeks US FDA approval for blood cancer therapy

Gilead Sciences Inc. has filed for approval with the U.S. Food and Drug Administration for an investigational cancer therapy that treats a rare cancer of the white blood cells.

The Foster City, Calif.-based company's biologics license application is for the chimeric antigen receptor T cell therapy KTE-X19. The drug treats adult patients with mantle cell lymphoma whose disease has returned or is resistant to prior therapies. CAR-T cell therapies involve infusing patients with lab-enhanced versions of their own cells to help fight cancer cells.

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma typically affecting men over the age of 60.

KTE-X19 is not yet been approved anywhere in the world but has previously received a breakthrough therapy tag from the FDA and a priority medicine designation from the European Medicines Agency.

Gilead inherited the drug after the acquisition of Kite Pharma Inc. in 2017.

The application is based on data from a mid-stage study called Zuma-2, which showed 93% of the 60 patients responded to the therapy, including 67% of patients who had no signs of cancer remaining after a single infusion.

Gilead plans to file for marketing authorization for KTE-X19 in Europe in early 2020.