Words by Isabel O’Brien
Astellas Pharma has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its therapy to treat gastric cancer. The treatment is specifically approved for adults with inoperable or metastatic gastric or gastro-oesophageal junction cancer, to be used in combination with standard chemotherapy.
The therapy works by targeting and binding to specific cancer cells, aiding in their destruction. Clinical trials demonstrated that, when used with chemotherapy, the treatment significantly improved patient survival rates compared to a placebo. This approval follows its earlier clearance in Japan, marking it as the first targeted treatment globally for cancers involving a particular protein family commonly found in these types of cancers.
“This new targeted medicine can extend survival for adults with this type of cancer,” confirms Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access. “MHRA is assured that the appropriate regulatory standards of quality, efficacy and safety for the approval of this new medicine have been met.”
While the therapy is now cleared for the UK market, its approval in the US has been delayed due to third party manufacturing issues cited by the FDA. Astellas has resubmitted its application, with a decision expected by 9 November 2024. Astellas has yet to provide details regarding the pricing and availability of the therapy in the UK.
