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                                    <figcaption>Johnson &amp; Johnson’s Akeega has gained approval from the FDA in BRCA2-mutated mCRPC, marking the second prostate cancer indication in which the therapy has been approved. Image credit: PixelBiss via Shutterstock.com.</figcaption>
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<p>Johnson &amp; Johnson (J&amp;J) has secured a US label expansion for its next-generation oncology combination, Akeega, in breast cancer gene 2 (BRCA-2)-mutated, metastatic, castration-sensitive prostate cancer (mCSPC).</p>



<p>A combination of GSK’s Zejula (niraparib) and J&amp;J’s androgen inhibitor, Zytiga (abiraterone) in a pill format, J&amp;J’s therapy received FDA approval in mCSPC based on positive results of the Phase III AMPLITUDE study (NCT04497844), which found that Akeega plus prednisone and androgen deprivation therapy (ADT) cut the risk of disease progression or death by 54% compared with standard of care (SoC).</p><div>
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<p>J&amp;J gained the rights to investigate and commercialise Zejula in prostate cancer from the drug’s creator, Tesaro, which was later acquired by GSK in 2018.</p><div id="slot-one"></div><div id="Sgpollsputhere"></div>



<p>The current SoC for mCSPC revolves around the use of an androgen receptor signalling inhibitor such as Zytiga, plus prednisone and ADT.</p>



<p>J&amp;J said that this approval makes Akeega plus prednisone the first FDA-approved precision medicine combination treatment for patients with BRCA2-mutated mCSPC.</p>



<p>By besting the current SoC, Akeega could also be poised to become the treatment standard alongside ADT and prednisone, marking a potential change to SoC.</p><div> 
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<h2 id="h-akeega-s-prostate-cancer-market-potential">Akeega’s prostate cancer market potential</h2>



<p>Akeega’s approval furthers J&amp;J’s legacy in the mCSPC market, as the company originally developed and marketed Zytiga. Before the therapy lost exclusivity in 2018, it was a blockbuster seller, making $2.5bn for J&amp;J at the peak of its annual sales.</p>



<p>Akeega was first approved in the US for use in patients with BRCA-positive, metastatic castration-resistant prostate cancer (mCRPC) in 2023. This label expansion furthers J&amp;J’s reach in the prostate cancer space, which has become highly competitive following the approval of PARP inhibitors. These include Pharmaand’s Rubraca (rucaparib) and MSD and AstraZeneca’s Lynparza (olaparib) for mCRPC patients.</p><div id="slot-two"></div>



<p>Pfizer’s PARP inhibitor, Talzenna (talazoparib), also gained FDA approval for use alongside androgen receptor inhibitor Pfizer and Astellas’ Xtandi (enzalutamide) in this patient group.</p>



<p>According to GlobalData’s Pharma Intelligence Center, Xtandi was the best-selling mCRPC drug of 2024, bringing in $5.9bn for Pfizer and Astellas.</p>



<p>A patient-based forecast from GlobalData predicts that Akeega will reach peak sales of $676m in 2030 while profits associated with the drug will drop to $205m the following year.</p>



<p>GlobalData is the parent company of <em>Pharmaceutical Technology</em>.</p>
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<p>Johnson & Johnson's Akeega has received FDA approval for label expansion in BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This approval, based on the Phase III AMPLITUDE study, marks Akeega as the first FDA-approved precision medicine combination treatment for BRCA2-mutated mCSPC, potentially changing the standard of care. Akeega, a combination of GSK’s Zejula and J&J’s Zytiga, previously approved for mCRPC, enhances J&J's presence in the competitive prostate cancer market.</p>

J&J gains label expansion approval for Akeega in mCSPC