tafasitamab

BioMarin stands tall with first approved drug for rare disease that causes dwarfism

The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common cause of dwarfism. The commission also granted conditional approval to a cancer drug from partners Incyte and MorphoSys.

Incyte, MorphoSys’ CAR-T rival tafasitamab approved in EU

Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for patients with certain types of lymphoma. The European Commission has approved tafasitamab in combination with Bristol-Myers Squibb’s Revlimid (lenalidomide), followed by the antibody on its own, for the treatment of …

Incyte, MorphoSys’ CAR-T rival tafasitamab approved in EU Read More »

MorphoSys and Incyte’s Minjuvi (tafasitamab) + Lenalidomide Receive EC’s Approval for the Treatment of R/R DLBCL

Shots: The conditional approval is based on the P-II L-MIND study evaluating the safety and efficacy of tafasitamab + lenalidomide in patients with r/r DLBCL who are not eligible for ASCT Results: ORR (56.8%); CR rate (39.5%); PR rate (17.3%) as assessed by an IRC; m-DoR (43.9mos.) after a minimum follow up of 35mos. Tafasitamab …

MorphoSys and Incyte’s Minjuvi (tafasitamab) + Lenalidomide Receive EC’s Approval for the Treatment of R/R DLBCL Read More »

Incyte and MorphoSys Report First Patient Dosing in P-III frontMIND Study of Tafasitamab + Lenalidomide as a 1L Treatment for DLBCL

Shots: The first patient has been dosed in the P-III frontMIND study evaluating tafasitamab + lenalidomide + R-CHOP vs R-CHOP alone as a 1L treatment for high-intermediate and high-risk ~880 patients with DLBCL The 1EP of the study is PFS and 2EP include event-free survival, OS, metabolic CRR, and ORR The preliminary data from the …

Incyte and MorphoSys Report First Patient Dosing in P-III frontMIND Study of Tafasitamab + Lenalidomide as a 1L Treatment for DLBCL Read More »

FDA approves MorphoSys, Incyte’s drug for vulnerable lymphoma population

The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is designed for patients unable to tolerate such intensive treatments.

MorphoSys Reports Submission of Tafasitamab’s BLA to the US FDA to Treat Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)

Shots: The BLA submission is based on L-MIND P-II trial data results assessing Tafasitamab + lenalidomide in patients with r/r DLBCL and retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received Tafasitamab + lenalidomide vs lenalidomide monothx Re-MIND has met its 1EPs and has shown improved ORR of the …

MorphoSys Reports Submission of Tafasitamab’s BLA to the US FDA to Treat Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL) Read More »