trending Market Intelligence /marketintelligence/en/news-insights/trending/sgyx54b0xyzwwmdlysbwga2 content esgSubNav
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us
In This List

Novartis' rare blood cancer drug approved by US FDA to treat children

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help


Novartis' rare blood cancer drug approved by US FDA to treat children

Novartis AG's Tasigna received the U.S. Food and Drug Administration's approval to expand its usage to treat children with a rare type of blood cancer.

The drug is now approved to treat adults and children one year of age or older with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, or Ph+ CML-CP, a type of chronic myeloid leukemia which accounts for about 3% of newly diagnosed childhood leukemia worldwide.

Tasigna is also approved in the U.S. to treat adults and children with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor therapy and prior therapy that included Novartis' Gleevec, or imatinib.

Ph+ CML-CP involves body producing malignant white blood cells in patients with a genetic abnormality known as the Philadelphia chromosome. Philadelphia chromosome produces a protein called BCR-ABL that causes the chronic myeloid leukemia cells to grow and reproduce out of control.

The latest approval is based on two studies which demonstrated a cumulative major molecular response rate of 64% among newly diagnosed children and 47.7% where the patients were resistant or intolerant to prior therapy.

A major molecular response means that the amount of BCR-ABL gene in the blood is 1/1000th, or less, of what is expected in someone with untreated chronic myeloid leukemia.