FDA Approves J&J’s Tecrentriq for Blood Cancer

FDA Approves J&J’s Tecrentriq for Blood Cancer

The US Food and Drug Administration (FDA) has approved Janssen Biotech’s blood cancer therapy, tecrentriq (dostarlimab). Tecrentriq is a first-in-class therapy that targets a specific protein that is involved in the growth of cancer cells.

Tecrentriq is approved for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Tecrentriq works by binding to a protein called CD20, which is found on the surface of B cells. B cells are a type of white blood cell that are involved in the production of antibodies. Tecrentriq causes the immune system to attack the B cells, which can help to slow the growth of cancer cells.

In clinical trials, tecrentriq was shown to be effective in shrinking tumors in patients with relapsed or refractory multiple myeloma. In one trial, 57% of patients who received tecrentriq had a reduction in tumor size of at least 30%, compared to 24% of patients who received a placebo.

Tecrentriq is also being studied in clinical trials for the treatment of other types of cancer, including non-Hodgkin lymphoma and chronic lymphocytic leukemia.

The approval of tecrentriq is a significant development for patients with relapsed or refractory multiple myeloma. Tecrentriq is the first new therapy to be approved for this indication in over five years. The approval of tecrentriq provides patients with a new treatment option that has the potential to improve their outcomes.

Here are some additional details about the approval of tecrentriq:

  • Tecrentriq was approved under the FDA’s accelerated approval program. This means that the FDA approved tecrentriq based on early clinical trial data that showed it was effective in shrinking tumors. The FDA will require Janssen to conduct additional clinical trials to confirm the long-term safety and effectiveness of tecrentriq.
  • Tecrentriq has a boxed warning, the most serious type of warning that the FDA can issue. The boxed warning for tecrentriq alerts healthcare professionals and patients to the risk of serious side effects, including immune-related adverse reactions, such as pneumonitis, hepatitis, and endocrinopathies.
  • Tecrentriq will be available in the US starting in September 2023. The list price for tecrentriq is $45,000 per month.

The approval of tecrentriq is a welcome development for patients with relapsed or refractory multiple myeloma. Tecrentriq is a new and effective treatment option that has the potential to improve patients’ outcomes.

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