-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Article source: Medical Rubik's Cube Info
On September 20, Genmab/Seagen announced that the FDA has accelerated the approval of Tivdak (tisotumab vedotin) for the treatment of recurrent or metastatic cervical cancer during or after chemotherapy
.
This is the first FDA-approved antibody drug conjugate targeting tissue factor (TF)
Tissue factor is a membrane protein expressed in a variety of solid tumor cells, and is associated with tumor growth, angiogenesis, metastasis, and poor clinical prognosis
.
The FDA’s accelerated approval is based on an open-label, multi-center, single-arm phase II trial code-named innovaTV 204.
A total of 101 patients with recurrent or metastatic cervical cancer received tisotumab vedotin treatment.
These patients had previously received tisotumab vedotin.
No more than two systemic treatment regimens, including at least one platinum-based chemotherapy regimen
.
The results showed that the independent review committee (IRC) based on the RECIST v1.
1 assessment confirmed objective response rate (ORR) of 24% (95% CI; 15.
9-33.
3)
.
The median duration of response (DOR) was 8.
Tivdak’s prescription information includes black box warnings for ocular toxicity, as well as warnings for peripheral neuropathy, bleeding, pneumonia, and embryo-fetal toxicity
.
Cervical cancer originates from cells in the lining of the cervix and is one of the leading causes of cancer deaths in women worldwide
.
More than 311,000 cases die every year .
Tivdak is jointly developed by two companies, Genmab/Seagen, and both parties share the cost and profit at a 50:50 ratio
