US FDA approved new medicine Imfinzi that contains active pharmaceutical ingredient durvalumab for the treatment of metastatic urothelial carcinoma that is not responding to platinum containing chemotherapeutic drugs. Imfinzi/Durvalumab belongs to a pharmacological class termed as monoclonal antibodies that targtet programmed death ligand-1 (PD-L1).
Moreover, US FDA approved this indication under accelerated approval pathway based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Urothelial carcinoma (Transitional cell carcinoma) is type of carcinoma that affects urinary tract most likely ureter, urethra and urachus. It is highly progressive form of malignant tumor that arises from transitional epithelium (Urothelium). This type of tumor readily spread to nearby tissues and is difficult to eradicate completely. Urothelial carcinoma has high recurrence rate even after surgical resection. Symptoms of urothelial carcinoma are not obvious and vary from patient to patient. However, some pre-defined symptoms are small amount of blood in urine, consistent pain in back due to tumor pressure, weakness, painful micturition , unexplained weight loss.
Exact underlying mechanism is not fully understood but many scientist and researchers presumed that genetic predisposition, smoking, being old age, exposures to chemicals in chemical processing industries like paints, petroleum products, toxic compounds like aniline double the risk of urothelial carcinoma.In some, patients it is also associated with prostate gland. Certain drugs like cyclophosphamide and chronic bladder infections are also known to cause urothelial carcinoma.
Imfinzi/Durvalumab Side effects
According to data provided by health authorities this drug showed following side effects during clinical trials
- Muscular pain
- Loss of appetite
- Drug induced colitits
- Increase risk of infection
- Hypersensitivity reactions
- Infusion related reactions
- Mild fever
Imfinzi/Durvalumab Uses/Patient Information
US FDA approved Imfinzi/Durvalumab for the treatment of advance progressive urothelial carcinoma that is not responding to other chemotherapeutic drugs like platinum containing drugs. This drug can also be used in combination with other chemotherapeutic agents to get more efficacious results. Moreover, initial studies conducted by health authorities also suggest that imfinzi/durvalumab may pose risk to fetal development so it should be avoided in pregnancy.
Imfinzi is formulated as 120mg/2.4mL (50mg/mL) single-dose vial and 500mg/10mL (50mg/mL) single-dose vial. However, standard dosage frequency of imfinzi is 10mg/Kg intravenously via infusion over 1 hr. In case of toxicity or severe adverse effects like pneumonitis, hepatitis or colitis withhold or discontinue drug to manage such adverse effects.