NEW CANCER TREATMENTS ARE ON THEIR WAY TO APPROVAL - THE THREE NEW DRUGS BEING PROMOTED - Filenews 31/3 by Marilena Panayi
At least three of the five new drugs currently being promoted for approval in the European Union are cancer treatments, with a focus on aggressive forms such as small cell lung cancer and bladder cancer, signaling new mobility in the European therapeutic arsenal of oncology.
In the latest decisions of the European Medicines Agency (EMA) and preparations for rare and very rare diseases intended for both adults and children.
Specifically, and as can be seen from what was announced last Friday by the EMA, at the heart of the developments is the recommendation of the competent committee (CHMP) for the approval of tarlatamab (Imdylltra), a new immunotherapy for small cell lung cancer of the advanced stage, one of the most aggressive forms of cancer with limited treatment options after the disease has recurred.
The available data, as recorded in the relevant announcement, show a significant improvement in overall survival compared to existing treatments, a development that is considered particularly important for a category of patients with an unfavorable prognosis and limited alternatives.
In the same context, the recommendation for the preparation Zepzelca (lumbinectin), which is recommended as a maintenance treatment in patients with small cell lung cancer, whose disease has not worsened after initial treatment.
At the same time, a positive opinion was given for the preparation Adstiladrin (nadofaragene firadenovec), a new gene therapy aimed at patients with bladder cancer who do not respond to the basic available immunotherapy. These are patients with an increased risk of developing the disease, for whom treatment options have been limited to date.
In addition to cancer treatments, the CHMP recommendations also include medicines for rare and serious conditions.
Among them is the Commission's positive opinion on Joenja (leniolicib), which is intended for the treatment of activated phosphoinositide 3-kinase delta (APDS) syndrome, a rare inherited disorder of the immune system that can lead to serious infections and progressive deterioration of patients' health.
This development is considered particularly important for patients with rare diseases, for whom available treatment options remain limited.
Of particular importance is also the recommendation for paediatric use of Bopediat (furosemide), which is intended for the treatment of edema of cardiac, renal or hepatic origin, as well as hypertension in children with chronic kidney disease.
At the same time, the CHMP recommended extensions of therapeutic indications for a number of medicines already authorised in the European Union, extending their use to new categories of patients.
The final marketing authorisation decisions will be taken by the European Commission, followed by evaluation procedures at Member State level on the price and reimbursement of medicines, which will determine the timing of their inclusion in daily clinical practice.
