The FDA has approved Keytruda (pembrolizumab; Merck) in combination with axitinib (Inlyta; Pfizer), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma.
The approval was supported by data from a phase 2 multicenter, open-label, single-arm trial (N=87) of patients with locally advanced or metastatic bladder cancer with FGFR3 or FGFR2 genetic alterations that had progressed following treatment with chemotherapy.
The Food and Drug Administration (FDA) has issued a warning letter to CanaRx, a company operating as a prescription drug provider, for its involvement in the distribution of certain unapproved or misbranded drugs that may be harmful to US consumers.
Two large trials show benefits for pembrolizumab-axitinib and avelumab-axitinib versus sunitinib
TICE BCG is indicated for the treatment and prophylaxis of carcinoma in situ of the urinary bladder and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection.
UGN-1 is an investigational formulation of mitomycin, delivered to patients using standard intravesical catheters.
The researchers found that treatment was associated with a 30% reduction in death, while having multiple complex conditions was associated with a 72% increase in death in unweighted multivariable analysis.
The colon cancer was no longer seen during colonoscopy at 16 months after pembrolizumab initiation; no hypermetabolic activity was seen in positron emission tomography in any previously documented site of disease.
There was a 70% complete overall response rate among those with prior immune checkpoint inhibitor treatment.
The Dako PD-L1 IHC 22C3 PharmDx Assay has been approved as a companion diagnostic to identify patients with with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda.
