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

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

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.

More from New Products

Boehringer Still Sees Plenty Of Juice In Jardiance

 
• By 

Strong sales growth for the German group’s SGLT2 inhibitor in 2024

Pipeline Watch: Seventeen 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.

Sanofi Set To Shake Up Crowded Hemophilia Space After Qfitlia Approval

 
• By 

The small interference RNA therapeutic can be used by patients regardless of inhibitor status.

Unicycive Approaches Its First Approval, But In A Competitive Space

 

The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.

More from Scrip

AIRNA To Take RNA Editing Into The Clinic With $155m Series B Round

 
• By 

CEO Kris Elverum told Scrip about the start-up’s platform for editing RNA to correct genetic variants that cause harm and to reproduce healthy variants as a means of treating disease.

Axsome Plans Excessive Sleepiness Study In Depression After Phase III Failure

 

The study’s failure in the overall MDD population was not a surprise, but solriamfetol’s efficacy in MDD with EDS provided a rationale for testing it in that subpopulation.

Will They Or Won’t They? Tariff Question Looms For Drugmakers

 

Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.