Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has given the green light to its therapy treatment for patients with multiple myeloma. The treatment belongs to J&J’s subsidiary, Janssen Pharmaceuticals.
The therapy is called teclistamab and it’s branded as Tecvayli. It’s a treatment option for patients suffering from multiple myeloma that has returned despite the patients receiving multiple classes of therapies – specifically, four or more.
According to a company spokesperson, the therapy will be available in the first week of November and cost $39,500 on a monthly basis. The overall price for a 10-month course will range from $355,000 to $395,000.
Overall, Tecvayli is Janssen’s fourth treatment specific to multiple myeloma that has been approved. This strengthens the company’s oncology portfolio and demonstrates its dedication to finding and developing treatments for this uncommon blood cancer.
Michael Andreini, the CEO of the Multiple Myeloma Research Foundation, stated, “We are greatly encouraged by the FDA’s approval of teclistamab and Janssen’s commitment to the multiple myeloma community. Multiple myeloma is a life-threatening disease with considerable unmet need, and teclistamab is an important new treatment option for patients who have faced multiple relapses. ”
Peter Lebowitz, Global Therapeutic Area Head of Oncology at Janssen/J&J, was delighted at the FDA approval. He said that the FDA’s thumbs-up strengthens the company’s already stacked oncology portfolio and provides them with the impetus to keep working hard to develop cancer treatments in the future.
“MajesTEC-1” is the name of the study used to assess the security and efficacy of Tecvayli. It’s a two-phased open-label, single-arm clinical trial for adults with relapsed multiple myeloma with three prior lines of therapy or more. In the crucial Phase 2 of the trial – which had patients with a median of five prior lines of therapy – an overall response rate of nearly 62% was achieved. Most notably, 28.2% of the participants showed a complete response (CR) or better.
It must be noted, however, that the approval isn’t straightforward; it comes with a warning about the possibility of Cytokine Release Syndrome (CRS) and Neurologic Toxicity. In the safety population of the MajesTEC-1 clinical trial, the most common adverse reactions – found in more than 20% of the population – were nausea, pneumonia, diarrhea, headache, fatigue and pyrexia, among others.
During the clinical trial, 72% of the patients who took the recommended dosage of Tecvayli experienced CRS. After receiving additional Tecvayli doses, a very small proportion of patients – less than 3% – experienced their first occurence of CRS.
Despite the fact that multiple myeloma is relatively rare compared to prostate or breast cancer, it is still regarded as a common form of blood cancer. It develops in the bone marrow and, if not diagnosed and treated early, has the potential to spread throughout the body.
According to J&J, people between the ages of 65 and 74 are the most likely to be diagnosed with multiple myeloma, and men are generally more affected than women. According to the American Cancer Society, this year will likely see the diagnosis of close to 35,000 new cases of multiple myeloma in the country.
