Copanlisib FDA-approved for Relapsed Follicular Lymphoma in Adults

Highlights:

• Copanlisib has received accelerated approval by the US FDA for the treatment of relapsed follicular lymphoma in adults
• The approval is based on the results of the Phase II CHRONOS-1 study
• Larger clinical trials will determine its continued approval for the condition

Copanlisib, a kinase inhibitor, has received accelerated approval from the US Food and Drug Administration (FDA) for the treatment of follicular lymphoma in adults that has relapsed despite at least two prior treatments. The approval comes following the positive results with the drug in a part of the Phase II clinical trial called the CHRONOS-1 study. The study was conducted on 104 patients with follicular B-cell non-Hodgkin lymphoma who suffered from relapse despite at least two prior treatments. It was found that:

• Fifty nine percent of patients who took copanlisib experienced a complete or partial shrinkage of the tumor. Among these, 14% experienced a complete response.

• The effect lasted for a median duration of 12.2 months.

• The safety aspects were similar to those that were published earlier. Side effects included low white blood cells and platelet counts, increased incidence of infections, high blood sugar levels, high blood pressure, nausea, diarrhea, a decrease in general strength and energy, non-infectious inflammation of the lung tissue, and severe skin reactions. Serious side effects occurred in 26% patients.

Copanlisib was also earlier granted Orphan Drug Status, since it is used for a rare condition, and thus its development will receive incentives associated with the status.

Though copanlisib has received accelerated approval, its clinical trials will continue to confirm the efficacy and safety of the drug in follicular lymphoma. In fact, two large scale studies are underway: CHRONOS-3 Phase III study where copanlisib is being used in combination with another drug rituximab and the CHRONOS-4 Phase III study, where copanlisib is being used in combination with standard immunochemotherapy

The approval of copanlisib by the FDA may also pave the way for approval in other countries as well.

About Follicular Lymphoma

Follicular lymphoma is a slow growing type of non-Hodgkin’s lymphoma, a type of cancer that affects the immune cells. The lymph nodes, spleen and bone marrow are often affected. Most affected people have a mutation in the bcl-2 gene. Treatment options include rituximab, chemotherapy or a combination of the two. Unfortunately, patients often show relapses after treatment. Several other treatments like vaccines, and bone marrow and peripheral stem cell transplantation are also being evaluated.

About Copanlisib

Copanlisib is a phosphatidylinositol-3-kinase (PI3K) inhibitor that is administered intravenously as an infusion over 1 hour. It inhibits the enzymes involved in cell growth. It should not be used by pregnant or breastfeeding women. It is administered on days 1, 8, and 15 of a 28-day treatment cycle followed by a week’s break

Reference:

1. FDA approves new treatment for adults with relapsed follicular lymphoma - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576129.htm)

Source-Medindia