1. Scrip
  2. >>New Products

Morphosys/Incyte’s Monjuvi Wins Early US FDA Approval In Second-Line DLBCL

MAb’s CAR-T Like Efficacy Seen Giving Wide Adoption

 
• By Sten Stovall

Monjuvi’s good efficacy and safety profile should enable its broad adoption in the second line DLBCL space and help it compete well against rival CAR-T therapies, analysts said.    

Lymphoma
MorphoSys, Incyte to co-commercialize Monjuvi in the US • Source: Shutterstock

Commercial supplies of Incyte Corporation and MorphoSys AG’s novel CD19-targeting monoclonal antibody will be available in the US by the end of this week after Monjuvi (tafasitamab) won early approval there as a second-line treatment of relapsed or refractory diffuse large B-cell lymphoma. The companies said the patient population size they would be initially targeting there was around 10,000 per annum.

The CD19-directed cytolytic antibody is now indicated as a second-line therapy in combination with Celgene’s Revlimid (lenalidomide) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL

More from New Products

Pipeline Watch: Thirteen 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.

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
• By Jessica Merrill

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

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.

Merck KGaA Seals SpringWorks Buy

 
• By Kevin Grogan

The German group is paying $3.9bn to get hold of the US firm and its two approved products.

More from Scrip

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: AstraZeneca CEO cautions Europe; Pfizer CEO optimistic on US tariffs, pricing; Merck & Co reassures on pipeline; Merck KGaA buys SpringWorks; and Akeso explains ivonescimab overall survival data.