Medical Communication

January 2022: EMA approves dossier for new indication for drug in metastatic colorectal cancer

By January 21, 2023 No Comments

During most of 2021, Meducom worked hard to support a client and clinical experts in the field with the development and submission of a dossier to EMA for a new indication for an oncological drug in the treatment of metastatic colorectal cancer. After an earlier submission and feedback round, this significantly updated and expanded dossier was submitted to EMA in October 2021 and received a positive CHMP opinion in December 2021. All involved in this long and intense process were extremely pleased to receive the formal EU approval for this new indication in January 2022. This new indication provided solid support to prescribe this oncological drug for those patients who could not continue their current treatment due to relevant and frequently seen side effects with their current treatment. Clearly, we at Meducom were very proud and honoured to have been able to provide such a relevant contribution, albeit behind the clinical scenes, to improve treatment options for patients with cancer.