Janssen granted additional European Commission approval for bispecific antibody
The approval provides the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.
In August 2022, TECVAYLI (teclistamab) became the first bispecific antibody targeting B-cell maturation antigen (BCMA) to be licensed in Europe for the treatment of RRMM.
The EC approval was supported by positive results from the company’s phase 1/2 MajesTEC-1 study, evaluating the safety and efficacy of teclistamab in patients with RRMM.
In addition, the latest data from the study was recently presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, 2-6 June, Chicago, and the 2023 European Hematology Association (EHA) Congress, 8-11 June, Frankfurt.
According to Janssen, the new variation allows healthcare professionals to tailor treatment approaches and offer a reduced, biweekly dosing schedule, based on a patient’s response and weight. The reduced dosing schedule also equates to fewer hospital visits, potentially giving back ‘valuable time’ to patients and their caregivers.
Edmond Chan, senior director EMEA therapeutic area lead haematology at Janssen, said: “Following the initial European Commission approval for teclistamab in August 2022, our research has remained focused on how we can continue to advance the use of teclistamab to better meet individual patient needs and improve patient experiences. Today’s approval for teclistamab provides eligible patients, their caregivers and physicians an additional, more flexible weight-based option with less frequent dosing depending on a patient’s response.”
Sen Zhuang, VP, clinical research and development at Janssen, added: “When advancing immune-based therapies such as teclistamab, tailored approaches are essential to allow us to respond to evolving data and evidence to find the most suitable balance of efficacy and safety. Today’s approval reinforces our focus on strengthening our multiple myeloma portfolio by investing in cutting-edge research that will help us continue to improve patient outcomes and importantly, their quality of life.”
Niels van de Donk, professor of hematology at Amsterdam University Medical Centers, commented: “Every patient’s experience with multiple myeloma is unique and requires a different treatment approach, tailored to their specific needs. With a decreased incidence of new onset Grade 3 or higher infections, low discontinuation rates and depth of responses maintained, this biweekly dosing option for teclistamab could provide substantial benefit for people living with multiple myeloma, potentially offering reduced time spent in hospital.”
