Durvalumab gets FDA nod for use with chemotherapy in locally advanced or metastatic biliary tract cancer

The FDA has granted approval to durvalumab, available as Imfinzi, in adult patients with locally advanced or metastatic biliary tract cancer. A PD-L1 checkpoint inhibitor, durvalumab is to be coadministered with cisplatin and gemcitabine. In patients with body weight ≥30 kg, the recommended dose is 1500 mg every 3 weeks when administered in combination with cisplatin and gemcitabine followed by 1500 mg every 4 weeks alone till the patient develops intolerable side effects or disease progression occurs. In patients weighing <30 kg, the dose is 20 mg/kg every 3 weeks with gemcitabine and cisplatin and then 20 mg/kg every 4 weeks…(Source: US FDA, Sept. 2, 2022).

FDA allows labeling change for finerenone

The FDA has approved an update to the label for finerenone, which will now include data from the phase III FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) cardiovascular outcomes study and the FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) trial conducted in type 2 diabetes patients with CKD, which showed a beneficial effect on cardiorenal outcomes. Finerenone, available as Kerendia, is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist. The label also includes a warning about hyperkalemia, which can occur as a side effect of the drug…(Source: Bayer Press Release, Sept. 2, 2022).

A new treatment option for generalized pustular psoriasis

Spesolimab (Spevigo) is the first drug approved by the FDA for the treatment of flares of generalized pustular psoriasis, which can adversely affect the quality of life for the patient and at times can cause potentially fatal complications. Spesolimab is a selective monoclonal antibody, targeting interleukin-36 involved in the flareup of the disease…(Source: Medscape, Sept. 2, 2022).

Enzyme replacement treatment for patients with acid sphingomyelinase deficiency

Olipudase alfa has been accorded FDA approval for the treatment of non-neurological symptoms in patients with the rare debilitating genetic disease, acid sphingomyelinase deficiency (ASMD) caused by the deficiency of the enzyme which breaks down sphingomyelin. This makes it the first drug available for this indication. As an enzyme replacement therapy, Olipudase alfa reduces sphingomyelin build up in the lungs, liver and spleen…(Source: US FDA, Sept. 2, 2022).