MedWatch

Roche awarded priority review status for Genmab drug rival

After a successful phase II/III study of its drug candidate mosunetuzumab, Roche has applied for marketing authorization from the FDA and been awarded priority review status.

Photo: Michael Buholzer/Reuters/Ritzau Scanpix

Roche’s monoclonal antibody Lunsumio (mosunetuzumab) has taken a big step towards becoming the first approved treatment for non-Hodgkin lymphoma, a form of cancer.

In a press release, Roche reveals the candidate has been awarded priority review status at the FDA, which cuts processing time from ten months to six. A marketing application has been submitted based on a successful pivotal phase II/III study.

Already a subscriber? Log in.

Read the whole article

Get access for 14 days for free.
No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.

  • Access all locked articles
  • Receive our daily newsletters
  • Access our app
An error has occured. Please try again later.

Get full access for you and your coworkers.

Start a free company trial today

More from MedWatch

Further reading

Related articles

Latest news

See all jobs