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FDA approved a pioneering ADC drug for the treatment of cervical cancer.
On September 20, 2021, Seagen and Genmab A/S jointly announced that the US FDA has accelerated the approval of the first antibody-conjugated drug (ADC) Tivdak for the treatment of recurrent and metastatic cervical cancer that continues to deteriorate. Tivdak is the first ADC drug approved for the treatment of this tumor.
Cervical cancer originates from cervical cells and is one of the main causes of death among female cancer patients worldwide. According to the American Cancer Society, in 2018, there will be about 13,000 new cases of cervical cancer and about 4,000 deaths in the United States; in 2021, there will be about 15,000 new cases of cervical cancer in the United States, and about 4,300 women will die from the cervix cancer.
Globally, more than 310,000 women die from cervical cancer each year, and most of them occur in developing countries. In developed countries, although routine medical examinations and human papillomavirus (HPV) vaccines have reduced the incidence of cervical cancer, many women are still diagnosed with cervical cancer, and many of them will experience tumor recurrence and metastasis after chemotherapy.
Tivdak (tisotumab vedotin-tftv) is a new antibody drug conjugate (ADC) targeting tissue factor (TF). Tissue factor is an antigen expressed on the surface of cervical cancer cells. Tivdak is endocytosed by cells and releases the toxic drug MMAE, which can disrupt the microtubule network of dividing cells, leading to cell cycle arrest and cell death.
The approval of Tivdak is based on the results of a key Phase II clinical trial. These patients have received up to two anti-cancer drugs of chemotherapy, including at least one treatment plan containing platinum chemotherapy. The test results showed that Tivdak achieved an objective response rate (ORR) of 24%, with a median duration of response (DOR) of 8.3 months, and it was safe and controllable. It can be seen that Tivdak as a monotherapy can provide objective relief with significant clinical significance. The most common adverse reactions of Tivdak are hair loss, nose bleeding, nausea and conjunctivitis.
The global cervical cancer drug market is expected to grow from 7.92 billion U.S. dollars in 2020 to 8.09 billion U.S. dollars in 2021, with a compound annual growth rate of approximately 2.1%. It is estimated that by 2025, the cervical cancer drug market will reach approximately 9.7 billion U.S. dollars. The compound annual growth rate will be 4.7%.
Roche’s Avastin will reach 3.38 billion U.S. dollars in global sales in 2021. Merck’s K drug (Keytruda) global sales reached approximately 14.4 billion U.S. dollars in 2020 and is expected to reach approximately 17.2 billion U.S. dollars by the end of 2021. The global increase in HIV infection rates and the increase in cervical cancer screening rates have both promoted the year-on-year growth of the cervical cancer drug market.
For female patients with recurrent or metastatic cervical cancer who have worsened after first-line chemotherapy, the available treatment methods are very limited. Therefore, a new treatment method has a huge and unmet clinical need. Clinical needs determine the value of the drug. The approved Tivdak is a very important good news for women patients with recurrent or metastatic cervical cancer. The approval of Tivdak will not only fill the clinical needs in the field of cervical cancer treatment, but will also create huge commercial value for companies such as Seagen.
FDA approved a pioneering ADC drug for the treatment of cervical cancer
(source:internet, reference only)