Bristol Myers Squibb’s Opdivo was recently granted FDA approval in combination with cisplatin and gemcitabine as a first-line treatment for metastatic urothelial carcinoma. With this approval, Opdivo positions itself to compete with Merck & Co’s immune checkpoint inhibitor Keytruda in combination with Astellas and Pfizer’s Padcev, a nectin-4-directed antibody-drug conjugate, according to GlobalData.
Tag Archive for: bladder cancer
The blockbuster immunotherapy secured separate late-stage victories as an adjuvant-setting treatment in renal cell carcinoma and muscle-invasive urothelial carcinoma.
The bladder cancer-focused company’s larger-than-expected Nasdaq debut on Thursday opens this year’s batch of planned initial public offerings, which include at least half a dozen biotechs.
Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.
The competitors posted promising survival data for their respective blockbuster PD-1 inhibitors—Keytruda and Opdivo—emphasizing the potential of these therapies in bladder cancer patients.
Merck on Thursday reported that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) met one of its dual primary endpoints in the Phase III AMBASSADOR trial in muscle-invasive urothelial carcinoma.
The drug was being studied in patients with types of urothelial carcinoma who are eligible for cisplatin-based chemotherapy.
GSK agreed to settle a U.S. lawsuit alleging its discontinued heartburn drug Zantac caused cancer, the British drugmaker said on Friday, preventing the first such case from going to trial next month.
A class-action lawsuit from thousands of third-party payers alleges that the companies broke racketeering laws to market their diabetes drug Actos, while not disclosing its bladder cancer risk.
The health regulator flagged application deficiencies related to the FDA’s pre-license inspection of the company’s third-party contract manufacturing firms.
