Roche T Cell Engager Bispecific Antibody Approved In Canada

Release Date: 31-Mar-2023

Bispecific antibodies have transformed the landscape of cancer treatment in the last decade, with as many as 10 bispecific antibodies having gained approval in different parts of the world in the last 8 years. Out of all pharmaceutical companies that have developed and introduced their bispecific antibodies in the market, Roche has been on the forefront with three of its bispecific antibodies getting approval from both the FDA and EMA. These are Hemlibra, Vabysmo and Lunsumio. Recently, Roche made headlines again after bagging the market approval for another bispecific antibody candidate from its pipeline in 2023. With Hemlibra commercially having become the most successful bispecific antibody in the global cancer therapeutics market, Roche played an important role in bringing attention to the field and contributing to the overall growth of the bispecific antibodies market.


The drug Glofitamab, which will be marketed by Roche as Columvi, was approved by Canada’s health regulatory agency Health Canada on March 24, 2023. With this, Columvi became the fifth bispecific antibody to be developed and commercialized by Roche or its subsidiary Genentech. Glofitamab was granted approval for the treatment of relapsed or refractory forms of diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma, and also the most common blood cancer affecting individuals globally. Currently, chemotherapy is the gold standard of treatment for diffuse large B-cell lymphoma, and with the approval of Glofitamab, patients in Canada now have another alternative treatment. This approval is for patients who have undergone two lines of systematic therapy or CAR-T therapy, or are not eligible or cannot receive CAR-T therapy.


Taking the same route as its previously approved bispecific antibody Lunsumio, Roche developed Glofitamab as a T cell-engaging antibody. With one of its arm binding to the CD3 protein complex on the T cells, Glofitamab brings them closer to the cancerous B-cell lymphomas by engaging their antigen CD20. However, unlike Lunsumio, Glofitamab has been developed to work even in the presence of other antibodies and treatments that engage the CD20, making it easier for it to be used in combination with other drugs against the same CD20 antigen. Additionally, Glofitamab is also a fixed duration treatment therapy, which is anticipated to play an essential role in cutting down the cost of therapy because other therapies for diffuse large B-cell lymphoma are required to be given over a long time, which can be expensive and unaffordable for some patients.


Roche already has a rich portfolio of drugs and immunotherapies for cancer and the addition of Glofitamab to it is obviously expected to increase its patient reach and market penetrance. Though the drug has gained approval only in Canada at present, approvals in the US and EU, followed by other prominent international markets are set to follow. The pharmaceutical giant had submitted a Biological License Application to the FDA earlier and in January 2023, the FDA accepted and granted it priority review. If it gets approved by the two agencies as well, Glofitamab will become the first fixed-duration, off-the-shelf therapy targeting the CD20 and CD3 in the major markets of the US and EU. The company expects a positive response from FDA to this application for approval, for which the FDA announced the deadline in July 2023.


Glofitamab is expected to join Roche’s Lunsumio, another CD20andtimes;CD3 antibody approved for the treatment of follicular lymphoma in late 2022, in the market by the end of 2023, adding to Roche’s ever-growing assortment of immunotherapies. Roche has been leading the market for bispecific antibodies and with its continuous feats in the cancer therapeutics market, it is well leading the development of more of these novel antibodies by setting an example for other pharmaceutical companies. Roche owns a major share of the global bispecific antibody market and is expected to keep holding the title as more of its bispecific antibodies get approved for commercial sale.

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