Enzalutamide by Pfizer for Transitional Cell Carcinoma (Urothelial Cell Carcinoma): Likelihood of Approval

Enzalutamide is under clinical development by Pfizer and currently in Phase II for Transitional Cell Carcinoma (Urothelial Cell Carcinoma). According to GlobalData, Phase II drugs for Transitional Cell Carcinoma (Urothelial Cell Carcinoma) have a 19% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Enzalutamide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Enzalutamide overview

Enzalutamide (Xtandi) is a phenylimidazolidine derivative, acts as anti neoplastic agent. It is formulated as soft gelatin capsules and tablets for oral route of administration. It is indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel, indicated for the treatment of metastatic prostate cancer. It is also indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).

Enzalutamide is under development for the treatment of non-metastatic castration-resistant prostate cancer, prostate cancer in patients with non-metastatic biochemical recurrence in the EU, China and Asia, and also for metastatic hormone-sensitive prostate cancer in the U.S, EU, Asia and Japan and for non-metastatic high risk hormone sensitive prostate cancer. The drug candidate is also under development for castration-resistant prostate cancer in the Japan as a tablet formulation. It is also under development for the treatment of androgen receptor positive (AR+) ovarian, epithelial ovarian cancer, primary peritoneal or fallopian tube cancer (following one, two and three prior therapies),  and pancreatic cancer. It is also under development for refractory/relapsed acute myeloid leukemia, multiple myeloma, acute lymphocytic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome, primary myelofibrosis, Hodgkin and Non-Hodgkin’s lymphoma, 

It was also under development for metastatic castration-resistant prostate cancer in Japan as a first line therapy and HER2 positive triple negative breast cancer in the U.S., EU, Japan and Asia-Pacific and hepatocellular carcinoma in the U.S, EU and Asia. It was also under development for spindle cell squamous cell carcinoma and HER2 positive breast cancer as a second line therapy and androgen receptor positive salivary cancer and COVID-19.

Pfizer overview

Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.

For a complete picture of Enzalutamide’s drug-specific PTSR and LoA scores, buy the report here.