Tremelimumab Accepted Under Priority Review in the US
Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.
AstraZeneca’s biologics license application (BLA) for tremelimumab has been accepted for Priority Review in the United States for the treatment of patients with unresectable hepatocellular carcinoma (HCC) in combination with Imfinzi. A supplemental BLA has also been submitted for Imfinzi.
This novel dose and combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), which refers to a single priming dose of the anti-CTLA4 antibody added to Imfinzi. Imfinzi and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC in January 2020.
According to AstraZeneca, HCC is the most common type of liver cancer and is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. Approximately 26,000 people in the US suffer from advanced, unresectable HCC each year. There is a critical unmet need for patients with HCC who face limited treatment options.
“The HIMALAYA Phase III trial showed an unprecedented three-year overall survival in this setting with a single priming dose of tremelimumab added to Imfinzi, highlighting the potential for this regimen to improve longer-term survival outcomes,” said Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, in a press release. “Patients with advanced liver cancer are in great need of new treatment options, and we are working closely with the FDA to bring this novel approach to patients in the US as soon as possible.”
Source: AstraZeneca
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
