BEERSE,
Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy.[1],[2] As the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter.[3]
'Despite important scientific progress, patients who develop relapsed and refractory disease after having been exposed to the three major drug classes have limited therapeutic options and generally face poor outcomes,' said
'The approval of teclistamab followed an accelerated approval pathway, supported via the EMA's PRIME scheme,' said
CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.[4]
The CMA was supported by positive results from the multicohort, open-label Phase 1/2 MajesTEC-1 study (NCT03145181 and NCT04557098), evaluating the safety and efficacy of teclistamab in adults with RRMM (n =165).[1],[5],[6] Patients received a weekly subcutaneous injection of teclistamab at a dose of 1.5 mg/kg, after receiving step-up doses of 0.06 mg/kg and 0.3 mg/kg.[1] In the study, 104 out of 165 patients achieved an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI]; range, 55.2-70.4) after a median of five prior lines of therapy.[1] Notably, 58.8 percent of patients receiving teclistamab achieved a very good partial response (VGPR) or better and 39.4 percent achieved a complete response (CR) or better.[1] The median time to the first confirmed response was 1.2 months (range, 0.2-5.5 months) and the median duration of response was 18.4 months (95 percent CI; range, 14.9-not estimable).[1]
Results from the MajesTEC-1 study were also published in
Adverse events (AEs) were consistent with this patient population. The most common AEs were cytokine release syndrome (72 percent; 0.6 percent Grade 3, no Grade 4), neutropenia (71 percent; 64 percent Grade 3 or 4) and anaemia (55 percent; 37 percent Grade 3 or 4).[1] Infections were frequent with the most common being upper respiratory tract infections (37 percent; 2.4 percent Grade 3 or 4) and pneumonia (28 percent; 19 percent Grade 3 or 4).[1] Hypogammaglobinaemia occurred in 123 patients (75 percent) and 39 percent of patients received intravenous or subcutaneous immunoglobulin therapy.[1] Neurotoxic events were low grade (15 percent; 14 percent Grade 1 or 2) and five patients (three percent) had immune effector cell-associated neurotoxicity syndrome.[1]
'With nearly 20 years of dedicated leadership in this area, our ambition to advance the best science to deliver novel therapies and regimens for the treatment of multiple myeloma is as strong today as it has ever been. We now look forward to collaborating with Health Authorities worldwide to make this treatment available to patients,' said
'This first approval for teclistamab worldwide marks significant progress for patients with relapsed and refractory multiple myeloma,' said
About Teclistamab
Teclistamab is a first-in-class, off-the-shelf (ready to use) bispecific antibody.[1] Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body's immune system to fight the cancer.[1]
The application for conditional marketing authorisation was reviewed by the Committee for Medicinal Products for Human Use (CHMP) under an accelerated timetable to enable faster patient access to this medicine.[8] This was also supported though the
Teclistamab is currently being evaluated in several monotherapy and combination studies.[7],[10],[11],[12],[13]
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.[14] In multiple myeloma, cancerous plasma cells change and grow out of control.[15] In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.[15] While some patients with multiple myeloma initially have no symptoms, others can have common symptoms of the disease which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels or kidney failure.[16]
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of
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