Henlius and Intas secure positive CHMP opinion for HETRONIFLY® as first-line therapy for advanced small cell lung cancer in Europe
Monday, September 23, 2024
Intas Pharmaceuticals has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of HETRONIFLY® (serplulimab) for use in European markets.
The CHMP's opinion is based on data from the ASTRUM-005 clinical trial, a randomised, double-blind, placebo-controlled international study that assessed the efficacy and safety of serplulimab in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
Lung cancer is the most commonly diagnosed cancer globally and has the highest mortality rate. In 2022, more than 2.48 million new cases were recorded worldwide, with small cell lung cancer accounting for 15-20% of these cases. Small cell lung cancer is particularly aggressive, with early metastasis, rapid progression, and poor patient outcomes.
Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody, was first developed by Henlius and has already been approved in China as Hansizhuang.
It has also received orphan drug designation from both the US Food and Drug Administration (FDA) and the European Commission for the treatment of small cell lung cancer (SCLC).
The treatment will be commercialised across more than 30 European countries by Accord Healthcare Ltd, a subsidiary of Intas. Accord, a key player in the global oncology market, supplies nearly one in three injectable oncology medicines in Europe.
This positive opinion marks a significant step towards making serplulimab available to patients across Europe.
Source: prnewswire.com
