FDA Approved Drugs: October, 2022

Imjudo (tremelimumab)

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer. HCC is the most common type of liver cancer.

Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

The approval was based on positive results from a Phase III trial (HIMALAYA), which demonstrated that patients treated with the combination of Imjudo and Imfinzi experienced a 22% reduction in the risk of death compared to sorafenib, an oral kinase inhibitor used to treat late-stage liver cancer. The results of the Phase III trial also showed evidence that the combination therapy allowed an estimated 31% of patients to live three years after administration, compared to 20% of sorafenib-treated patients, who showed the same longevity.

Beyond HIMALAYA, Imjudo is being tested in combination with Imfinzi across multiple tumour types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).

Imjudo is also under review by global regulatory authorities in combination with Imfinzi and chemotherapy in 1st-line metastatic NSCLC based on the results of the POSEIDON Phase III trial, which showed the addition of a short course of Imjudo to Imfinzi plus chemotherapy improved both overall and progression-free survival compared to chemotherapy alone.

Tecvayli (teclistamab-cqyv)

Janssen’s Tecvayli (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients 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 monoclonal antibody.

• Multiple myeloma is a cancer of the plasma cells in the bone marrow. Plasma cells normally make antibodies which fight infection, but when the plasma cells become malignant and develop into multiple myeloma, the myeloma cells proliferate and replace normal cells in the bone marrow.
• Tecvayli targets both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. BCMA is expressed at high levels on multiple myeloma cells. Tecvayli works by redirecting CD3-positive T-cells to BCMA-expressing myeloma cells to induce the killing of the cancer cells.
• Warnings and precautions associated with Tecvayli include hepatotoxicity, infections, neutropenia, hypersensitivity and other administration reactions, and embryo-fetal toxicity.
• Common adverse reactions observed in clinical trials include cytokine release syndrome, neutropenia, and anemia. Infections were frequent with the most common being upper respiratory tract infections and pneumonia. Hypogammaglobinemia and neurotoxic events were also observed in some patients.