The market holds Atezolizumab (Tecentriq), Pembrolizumab (Keytruda), Nivolumab (Opdivo), Durvalumab (Imfinzi), and Avelumab (Bavencio) as approved products targeting PD-1/PDL-1 pathway.
Merck’s Keytruda has been approved for patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Merck also initiated investigation of Keytruda for newly diagnosed bladder cancer but it failed in June 2020. However, Keytruda had its own victory as it become the first PD-1/L1 drug to win the FDA approval to treat non-muscle invasive bladder cancer that’s unresponsive to standard Bacillus Calmette-Guerin treatment.
The treatment course also employs high-energy radiations to kill cancer cells. Radiation therapy is often given along with chemotherapy to help the radiation to work well. In such circumstances, it is generally known as chemo-radiation. The management alternatives also comprise targeting specific growth factor receptor.
One of such molecules is Erdaftinib, marketed under the brand name Balversa, which is a pan-fibroblast growth factor receptor (FGFR) inhibitor for the treatment of cancers expressing activating mutations, amplification, and over-expression of fibroblast growth factors (FGFs). Balversa received US FDA approval for the treatment of patients with locally advanced or metastatic UC with certain FGFR mutations in April 2019.
Recently, in April 2020, another therapy (UGN-101) received approval from the US FDA and became the first approved therapy to treat low-grade upper tract urothelial cancer (LG-UTUC). UroGen Pharma’s UGN-101 (mitomycin gel; Jelmyto) is utilizing the company’s novel technology, i.e., RTGel/MitoGel technology platform for sustained release of the drug.
The approval was based on results from its pivotal phase III OLYMPUS trial, in which a final analysis showed that the drug elicited a complete response (CR) rate of 58% in this patient population. The drug has also been awarded Breakthrough Therapy Designation, Orphan Drug, and Fast Track Designations for LG-UTUC.