Gavreto® (pralsetinib) - new warning and precaution of severe and fatal infections

A Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to update healthcare professionals that severe and fatal infections, including opportunistic infections, have been reported in patients treated with Gavreto^®. An ad hoc analysis of results from the ongoing phase III trial AcceleRET-Lung demonstrated an imbalance regarding the risk of severe and fatal infection, including severe opportunistic infections, between the pralsetinib and standard of care arms. Healthcare professionals are advised to monitor patients closely for signs and symptoms of infection and treat appropriately. They are also advised to withhold Gavreto^® in the presence of active infection and discontinue Gavreto^® permanently if infections are life-threatening. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.