trending Market Intelligence /marketintelligence/en/news-insights/trending/0JAgy9VsW0uefvsC7fdCvA2 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.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • 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

J&J's blood cancer treatment granted breakthrough therapy tag by US FDA

Gauging Supply Chain Risk In Volatile Times

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


J&J's blood cancer treatment granted breakthrough therapy tag by US FDA

The U.S. Food and Drug Administration granted Johnson & Johnson's experimental blood cancer treatment JNJ-4528 its breakthrough therapy designation.

The regulator's designation is granted to accelerate the development and regulatory review of an investigational drug meant to treat a serious life-threatening disease.

J&J's Janssen Biotech Inc. unit is developing JNJ-4528 to treat patients of relapsed or refractory multiple myeloma who have previously undergone treatment. Multiple myeloma is a cancer that affects the plasma cells in the blood, which are responsible for producing antibodies.

Data from an ongoing phase 1b/2 study, dubbed Cartitude-1, supported the FDA designation. While J&J will present full results on Dec. 9 at the American Society of Hematology's annual meeting, data from the study, which is evaluating JNJ-4528 for treating the disease in adult patients, showed that the therapy reduced cancer in 90% of the patients.

The chimeric antigen receptor T cell, or CAR-T cell, therapy JNJ-4528 was previously granted the orphan drug designation by the FDA and priorities medicines, or PRIME, designation by the European Medicines Agency.

Amgen Inc. will also present results from a late-stage study of its multiple myeloma therapy Kyropolis at the ASH meeting. Also, Bristol-Myers Squibb Co. and bluebird bio Inc. released positive results from the KarMMa study which evaluated their CAR-T cell therapy ide-cel for the same indication.