Roche's Polivy ADC Is Approved As Another New Option For R/R DLBCL

The first-in-class anti-CD79b antibody-drug conjugate received a swift accelerated approval by the US FDA based on the results of a Phase Ib/II trial, for the same setting as CAR-T agents.

A young man' hand is displaying a thumbs up, indicating that he likes or approves of something - Image

Roche is launching Polivy (polatuzumab vedotin-piiq) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the US with an aim to move the first-in-class antibody-drug conjugate (ADC) into the front-line setting.

The anti-CD79b ADC was granted an accelerated approval from the FDA on 10 June based on the results of a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

What Incyte Investors Expect From New CEO Bill Meury

 

Fresh from having sold Anthos to Novartis, the new CEO is expected to update the oncology and dermatology-focused firm's strategy.

Bayer Buoyant After EU Nod For Twice-Yearly Eylea

 
• By 

Green light follows a recent rejection by the US FDA to partner Regeneron's request for an extension to the dosing interval.

Executives On The Move: New CEO At Atalanta Therapeutics

Recent moves in the industry include C-suite changes at Atalanta Therapeutics and Climb Bio, plus seven companies get new CMOs.