The world's first! Johnson & Johnson's "first-in-class" dual antibody became the fifth marketed bispecific therapy this year

Today, Johnson & Johnson's Janssen announced that the European Commission (EC) has approved the conditional marketing of Tecvayli (teclistamab), a bispecific antibody targeting the B-cell maturation antigen (BCMA), as a monotherapy for adult patients

This is the first time that teclistamab has been approved by

Multiple myeloma is the second most common malignancy of the hematologic system, accounting for about 10%

BCMA is a popular target for the treatment of B-cell blood cancers

The first bispecific therapy approved for the treatment of multiple myeloma and the first bispecific antibody approved to target BCMA, providing a "spot-type" treatment for refractory patients

The overall response rate reached 63%, and it is worth mentioning that 58.

Response rate data from Teclistamab in the MajesticTEC-1 trial (Image source: References[3])

Response rate data from Teclistamab in the MajesticTEC-1 trial (Image source: References[3])

The results of this clinical trial have been published

The median duration of remission was 18.

This year is not over, and five bispecific antibodies or fusion proteins have been approved by regulatory agencies around the world, more than the previous approvals of such therapies combined

The fact that bispecific antibodies can target two different antigens gives such molecules great flexibility

▲The potential mechanism of action of bispecific antibodies (Image source: References[4])

▲The potential mechanism of action of bispecific antibodies (Image source: References[4])

Resources:

Resources:

[1] Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) withEC Authorisation of First-in-Class Bispecific Antibody for the Treatment ofPatients with Multiple Myeloma.

[1] Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) withEC Authorisation of First-in-Class Bispecific Antibody for the Treatment ofPatients with Multiple Myeloma.

[2] Responses to Teclistamab Reported in Early-Phase Trial of HighlyRefractory Multiple Myeloma.

[3] Moreau et al.

[4] Labrijn et al.
, (2019).
Bispecific antibodies: a mechanistic review ofthe pipeline.
Nature Reviews Drug Discovery,https://doi.
org/10.
1038/s41573-019-0028-1