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Johnson & Johnson’s Janssen Pharmaceutical Companies Submits Marketing Authorization Application (MAA) to European Medicines Agency (EMA) Seeking Approval of Tarquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma (RRMM) ) has been submitted.
Multiple myeloma is an incurable blood cancer that affects plasma cells, a type of white blood cell in the bone marrow. In multiple myeloma, malignant plasma cells change and grow uncontrollably. More than 50,900 people in Europe were diagnosed with multiple myeloma in 2020, and more than 32,400 died.
Tarketamab is an investigational commercial (or ready-to-use) drug that targets both GPRC5D (a novel drug target present on some normal cells but overexpressed on myeloma cells) and CD3 on T. can) is a bispecific T cell engager antibody. -cell. It is administered by subcutaneous injection and is currently being evaluated in several monotherapy and combination therapies.
Dr. Edmond Chan, Senior Director of Hematology, Head of EMEA Therapeutic Area, Janssen-Cilag Limited, said: Patients respond to currently available treatment options. ”
He continues: […] This is important for improving patient outcomes, and we look forward to working with EMA to bring tarquetamab to those in need as soon as possible. ”
The marketing authorization application will follow the EMA’s approval of tarquetamab’s accelerated evaluation in November 2022. This shortens the time frame for MAA review. Granted when a drug has significant public health and therapeutic innovation interest.
The MAA is supported by data from the Phase 1 and Phase 2 first-in-human MonumenTAL-1 trial of tarketamab in patients with RRMM who had received at least three prior therapies. Initial Phase 2 results were presented at ASH 2022, and Phase 1 results were recently published in The New England Journal of Medicine.
Data presented at ASH 2022 show that subcutaneous talketamab achieved an overall response rate (ORR) of 74% at a dose of 0.4 mg/kg and 73% at a dose of 0.8 mg/kg given every two weeks I showed that. There is a median of 5 previous lines of therapy. This included proteasome inhibitors, immunomodulators, and anti-CD38 antibodies.
Dr. Peter Lebowitz, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC, said:[The] The European submission marks another important milestone in our progress and ambition to transform the treatment of multiple myeloma. ”
The MAA to the EMA also follows the Biologics License Application (BLA) to the FDA in December 2022.
In October 2022, Johnson & Johnson received FDA approval of Tecvayli, a BCMAxCD3 bispecific antibody for multiple myeloma, adding a broad range of available therapies for hematologic malignancies.
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