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Novartis’ Pluvicto receives MHRA marketing authorisation to treat advanced prostate cancer

The approval for the treatment applies to England, Scotland and Wales


Novartis’ radiogland therapy (RLT) Pluvicto – lutetium Lu 177 vipivotide tetraxetan – has received its first approval in Europe as a treatment for advanced prostate cancer from the Medicines and Healthcare Products Regulatory Agency (MHRA).

The marketing authorisation in Britain is specifically for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

The MHRA’s decision applies to England, Scotland and Wales, and the approval makes Pluvicto the company’s second radiogland therapy to be given a green light, after Lutathera (177Lu- oxodotreotide) which was approved for the treatment of neuroendocrine tumours.

The treatment’s availability on the NHS is subject to the conclusions drawn from a cost-effectivness assessment by the National Institute for Health and Care Excellence (NICE), which is anticipated to be finalised in November.

The US already offers Pluvicto as a treatment, following its approval from the US Food and Drug Administration (FDA) in March this year.

RLT is an emerging treatment option that has the potential to offer an alternative treatment pathway for some cancer patients. By combining a targeting compound – ligand – with a therapeutic radioactive atom – radioisotope – RLT delivers targeted radiation to cancer cells in the body and is administered via the bloodstream, with the purpose of limiting damage to surrounding tissue.

Locametz (gozetotide), a PSMA-targeted positron emission tomography (PET) imaging tracer, has also received a licence from the MHRA for use in imaging prostate cancer in Britain; the first diagnostic PSMA imaging tracer to receive this status from the MHRA.

Steve Allen, acting chairman of Tackle Prostate Cancer, said: “Today’s announcement of marketing authorisation for lutetium treatment is another positive milestone for eligible patients and their families. There continues to be a real and pressing need for better treatments for people with advanced prostate cancer. This new approach is very welcome.”

The MHRA based its decision for Pluvicto’s marketing authorisation on the alternate primary endpoint results from the phase 3 VISION trial – a randomised, open-label, international, multi-centre study where patients with progressive PSMA positive mCRPC treated with at least one androgen-receptor-pathway inhibitor and one or two taxane regimens.

The study showed that Pluvicto added onto standard-of-care reduced the risk of death by 38% compared to standard care alone in men with PSMA+ mCRPC who had progressed after three or more prior anti-androgen and chemotherapy regimens.

Article by
Fleur Jeffries

12th August 2022

From: Research, Regulatory



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