The EC approval is based on results from Phase 3 ASCEMBL trial, in which Scemblix nearly doubled the major molecular response rate compared to Bosulif, with a more than three times lower discontinuation rate due to adverse reactions
Novartis Campus, Forum 1, Banting 1 and Fabrikstrasse. (Credit: Novartis AG)
Swiss Pharmaceutical firm Novartis has received the European Commission (EC) approval for Scemblix (asciminib) to treat a type of chronic myeloid leukaemia (CML) in adult patients.
The drug is indicated for Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP), in adults who were previously treated with two or more TKIs.
Scemblix is a CML therapeutic that works by specifically targeting the ABL myristoyl pocket, also known as a STAMP inhibitor in scientific literature.
Its novel mechanism action is said to offer a new treatment approach for patients who experience intolerance or resistance to currently available TKI therapies.
Scemblix has been approved in several countries, including the US, Japan, Switzerland, and the UK, for treating Ph+ CML-CP in adult patients with intolerance to previous therapies.
The current regulatory approval is applicable to all 27 member states of the European Union (EI), along with Iceland, Norway and Liechtenstein, said Novartis.
Novartis Europe innovative medicines president Haseeb Ahmad said: “Approval of Scemblix from the European Commission is a critical milestone to help bring this novel treatment to patients living with CML in Europe.
“Building on more than twenty years of innovation in CML, we are excited by the potential to once again transform the standard of care for more patients around the world.”
The EC approval follows a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), granted in June this year.
It is based on results from the Phase 3 ASCEMBL trial, which evaluated the change in MMR rate with Scemblix, compared to Bosulif (bosutinib).
In the trial, the participants taking Scemblix experienced nearly doubled the MMR rate, compared to Bosulif (bosutinib), a TKI used for the treatment of Ph+ CML.
Also, the drug reduced the discontinuation rate due to adverse reactions by more than three times at the week-24, which is the primary endpoint.
Musculoskeletal pain, upper respiratory tract infections, fatigue, headache, arthralgia, increased pancreatic enzymes, abdominal pain, diarrhoea and nausea, include most common adverse reactions.
In October last year, the drug has been granted accelerated approval by the US Food and Drug Administration (FDA), Ph+ CML-CP in previously treated adult patients.
Furthermore, Novartis is pursuing regulatory approval for Scemblix in various countries worldwide.