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UK’s MHRA has issued a positive opinion for the Early Access to Medicines Scheme for radioligand therapy in patients with advanced prostate cancer.
Advanced Accelerator Applications (AAA), a Novartis company, announced on April 6, 2022 that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion for lutetium vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). The therapy was approved through the Early Access to Medicines Scheme (EAMS) and applies to PSMA-positive mCRPC patients who have been treated with androgen receptor (AR) Pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.
This positive opinion allows eligible patients in the UK early access to lutetium vipivotide tetraxetan while the MHRA completes its full marketing authorization application (MAA) review. The EAMS is meant to enable patients with life-threatening or seriously debilitating conditions to access medicines that have not yet been granted marketing authorization. These medicines are often filling a clear unmet medical need or providing an alternative treatment option.
Novartis received promising innovative medicine (PIM) designation for lutetium vipivotide tetraxetan in September 2021. Medicines must have received a PIM designation in order for the MHRA to provide a positive scientific opinion through EAMS.
“The positive scientific opinion for an Early Access to Medicines Scheme for lutetium vipivotide tetraxetan in this group of patients with a life-threatening disease shows the clear unmet medical need recognized by the MHRA,” said Dr. Gerhard Compion, medical lead at AAA, in a press release. “Patients who have metastatic prostate cancer classified as CRPC may have already had many lines of treatment before, including chemotherapy and hormone therapy. Their life expectancy is limited, and they may have run out of other treatment options. I am very relieved that eligible patients will now be able to access this radioligand therapy in England while the MHRA completes the Marketing Authorization Application review.”