Novartis' Pluvicto gets first European approval in GB

Novartis has secured its first approval in Europe for prostate cancer radioligand therapy Pluvicto, getting a green light from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Pluvicto (lutetium (177Lu) vipivotide tetraxetan) has been cleared for adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor inhibitors and taxane-based chemotherapy or not medically suitable for taxane drugs.

The approval – which applies to England, Scotland and Wales as Northern Ireland remains under EMA jurisdiction – gives Novartis its second radioligand therapy in Europe after Lutathera (177Lu- oxodotreotide) for neuroendocrine tumours.

Pluvicto is already available in the US after clearing an FDA review in March. NHS availability in Great Britain will depend on the outcome of an appraisal by cost-effectiveness agency NICE, which is due to conclude in November.

In the VISION study, Pluvicto given on top of standard 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.

After a median follow-up of 20.9 months, patients on Pluvicto had radiographic progression-free survival (PFS) of 8.7 months, compared to 3.4 months in the control group, while overall survival came in at 15.3 and 11.3 months, respectively.

The drug has been approved in Great Britain alongside Locametz (gozetotide), a PSMA-targeted positron emission tomography (PET) imaging tracer, which is used to identify patients suitable for treatment with the radioligand.

"Tragically, those diagnosed with metastatic prostate cancer will only have about a one in two chance of surviving five years," commented Steve Allen, acting chair of the Tackle Prostate Cancer patient organisation.

"Today's announcement of marketing authorisation for lutetium treatment is another positive milestone for eligible patients and their families," he added.

Pluvicto was the lead asset in Novartis’ $2.1 billion takeover of Endocyte in 2018, one of a series of recent deals that have boosted its presence in the radioligand category.

Analysts at Jefferies have previously predicted that sales could reach $600 million in the current indication, with additional upside if it gets approved for further uses, which could include the pre-chemotherapy setting in CRPC, as well as in metastatic hormone-sensitive prostate cancer (HSPC) patients who are treatment-naïve or with only short-term use of standard first-line hormonal therapies.

Novartis has suggested that Pluvicto could in time grow into a $2 billion product.