Bristol Myers Squibb proudly confirmed that they have officially received a European Commission’s approval stamp on Breyanzi® potential, a CD19-directed chimeric antigen receptor (CAR) T cell therapy. This therapy is for the treatment of adult patients group having refractory mantle cell lymphoma (MCL) or relapsed ones, after two rounds of systemic therapy involving a Bruton’s tyrosine kinase (BTK) inhibitor.
The senior vice president, Europe’s Bristol Myers Squibb, Emma Charles, said, “This permission for Breyanzi in refractory or relapsed mantle cell lymphoma is the next crucial step as we move on to serve on the commitment of the cell therapy for many suitable patients throughout Europe, as a fourth approval for Breyanzi in Europe. As seen, the frontline therapies have modernised in the past years for this rare but extreme form of non-Hodgkin lymphoma.”
Emma added, “Learning this, the number of patients who relapse or experience reduced survival outlook and become resistant has left a crucial need and an urge for a new treatment alternative. Breyanzi has the chance to identify a treatment depth and gap for this patient group on its precisely described clinical benefit.”
In the above statement, the decision was locked on the results fetched from the MCL group of TRANSCEND NHL 001. In this, the refractory or relapsed MCL adult patients were enrolled who had been dosed with two prior lines of therapy with a BTK inhibitor. From the patient group treated in the third line plus setting, the Breyanzi there described a high overall response rate of around 82.7% (95% CI: 72.7-90.2) and a 71.6% (95% CI: 60.5-81.1) complete response (CR) rate was recorded.
These were the study's initial and major secondary endpoints. After this, the responses were closely observed according to the months, and most of the patients are still seen in response at 24 months.
The safety results showed the level of consistency with the well-developed safety profile of Breyanzi seen throughout the approved indications and clinical trials, with an expected safety profile noticed in MCL with prior resolution. This extensive approval is accountable to every European Union (EU) member state and also the European Economic Area (EEA) countries Liechtenstein, Iceland and Norway.
The Breyanzi is also applicable in the EU for the adult patients with refractory or relapsed HGBCL, PMBCL, FL3B and DLBCL who relapsed between 12 months from refractory to or completion of first-line chemoimmunotherapy and the same as mentioned above.
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
