Everolimus not useful in women with kidney transplants: US FDA

Everolimus, however, slows infection and cancer in post-transplant patients

Everolimus, a kidney cancer drug currently sold under the brand name Afinitor by Novartis, is not useful in women having kidney transplant, according to US FDA, reports said.

Novartis is currently seeking an expanded use for everolimus to treat rejection of organs after kidney transplants.

However, everolimus doesn’t seem to be effective for kidney-transplant women patients  compared to a current treatment regimen, US FDA said.

A study which involved 1,335 patients compared two doses of everolimus to mycophenolic acid (Myfortic), another Novartis drug used in kidney-transplant patients The data showed both everolimus and Myfortic worked equally at preventing the body from rejecting a new kidney.

US FDA, however, indicated that everolimus treated patients showed a higher failure rate among women than mycophenolic acid (Myfortic).Everolimus group showed three times as many kidney rejections attributed to blood clots compared to the Myfortic group.

Death rates were similar in both groups “with more deaths attributed by FDA to the study drug” in the lower-dose everolimus group.

However, the everolimus group showed fewer cases of cytomegalovirus infections — a common viral infection associated with organ transplants leading to rejection of the transplanted organ – and cancer compared to the Myfortic group, US FDA said.

Everolimus tablets was approved by US FDA under the brand name Afinitor for the treatment of patients with advanced renal cell carcinoma after failure of treatment with Sunitinib or Sorafenib.

Everolimus belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).

While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), everolimus works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells.

US FDA had rejected Novartis’ application seeking approval for everolimus as a treatment to prevent the body from rejecting kidney and heart transplants way back in 2003, as well, citing the reason that drug could damage kidneys.

However, again submitted everolimus for treating advanced kidney cancer with addditional trial data.

A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that the growth or spread of the tumor was delayed when compared to patients who did not receive the drug.

In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug.

The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.