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.
‘Copanlisib, a drug that has recently been FDA approved for the treatment of follicular cancer, appears to be a good option to prevent relapses.’
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:
- FDA approves new treatment for adults with relapsed follicular lymphoma - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576129.htm)
Source: Medindia
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