J&J eyes prostate most cancers label enlargement for Akeega

The appliance comes sizzling on the heels of optimistic knowledge for Akeega unveiled at this 12 months’s American Society of Medical Oncology (ASCO) convention. Michael Vi by way of Shutterstock.

Johnson & Johnson (J&J) has utilized to the European Medicines Company (EMA) to increase the indication of Akeega (niraparib and abiraterone acetate) in prostate most cancers.

Akeega has been accredited in Europe for the therapy of metastatic castration-resistant prostate most cancers (mCRPC) together with steroid hormone prednisolone since 2023. J&J is now trying to widen the drug’s software to sufferers with metastatic hormone-sensitive prostate most cancers (mHSPC).

J&J’s drug is an possibility for sufferers the place medical or surgical therapy to decrease testosterone ranges has not labored, and in those that have BRCA 1/2 mutations – a subset of homologous recombination restore (HRR) mutations – in whom chemotherapy isn’t indicated.

Akeega combines the lively elements in GSK’s PARP inhibitor Zejula (niraparib) and J&J’s androgen blocker Zytiga (abiraterone). Given as a dual-action pill, the remedy works by focusing on DNA restore and inhibiting androgen manufacturing.

J&J gained prostate most cancers rights for Zejula from Tesaro in 2016, the latter firm was acquired by GSK.

The appliance comes sizzling on the heels of optimistic knowledge for Akeega unveiled at this 12 months’s American Society of Medical Oncology (ASCO) convention. Akeega decreased the danger of tumour development or demise by 37% in comparison with J&J’s prostate most cancers earlier blockbuster Zytiga (abiraterone acetate) within the Section III AMPLITUDE trial (NCT04497844).

Each therapies got alongside prednisolone, with Akeega outperforming Zytiga in different efficacy endpoints inside the HRR group. AMPLITUDE is the primary examine to point out the efficacy of mixing a PARP inhibitor and androgen receptor pathway inhibitor (ARPi) on this affected person inhabitants.

“Regardless of important progress in prostate most cancers, people with HRR gene alterations usually face restricted therapy choices, quicker onset of signs and poorer outcomes,” mentioned Henar Hevia, EMEA remedy space head of oncology at Johnson & Johnson Modern Drugs.

“With this submission to the EMA, we’ve the chance to supply sufferers with HRR-mutated mHSPC a therapy particularly focused to the underlying biology of their illness.”

Zytiga as soon as noticed peak annual gross sales globally of $2.5bn, although income has been slashed by the market entry of generics. J&J’s Akeega is forecast to generate income of $178m by 2031, in response to GlobalData’s Pharma Intelligence Centre.

Most of J&J’s prostate most cancers income is anticipated to come back from Erleada (apalutamide). The hormone remedy, accredited in 2019, is forecast to see annual gross sales of $5.3bn by 2031.

There’s fierce competitors within the prostate most cancers therapy panorama. AstraZeneca and MSD’s Lynparza (olaparib) has a spread of indications in males with prostate most cancers who’ve BRCA1 and BRCA2 mutations.

One other rival, Pfizer’s Talzenna (talazoparib), has the benefit of being accredited together with Xtandi (enzalutamide), a drug that Pfizer is partnered with Astellas for. The combo remedy is accredited for homologous recombination restore (HRR)-mutated mCRPC.

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