Leuprolide Acetate

The European Commission greenlit Astellas’ Xtandi (enzalutamide) with or without androgen deprivation therapy (ADT) for treating patients with high-risk biochemical recurrence (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) ineligible for salvage radiotherapy.The clearance announced Tuesday comes close on the heels of a favourable opinion adopted by the European Medicines Agency's (EMA) drug advisory body last month. “This expanded approval for Xtandi is a vitally important advance for patients with nmHSPC with high-risk BCR,” positioning it “as a new option for treatment in the early…setting,” said Ahsan Arozullah, head of oncology development at Astellas. The timing of the decision also coincides with the recently revised European Association of Urology (EAU) guidelines recommending Xtandi alone or with ADT as a new standard-of-care in this setting, following radiotherapy or surgery.The approval was backed by findings from the Phase III EMBARK study, which involved 1068 patients. Results showed that treatment with Xtandi plus leuprolide led to a significant 58% reduction in the risk of metastasis or death compared with leuprolide alone. The risk reduction was 37% in patients receiving Xtandi monotherapy.Xtandi, co-marketed by Pfizer in the US, secured FDA approval for the same indication in November and has previously been authorised for treating metastatic hormone-sensitive prostate cancer, as well as metastatic and non-metastatic castration-resistant prostate cancer.

“The extended approval allows enzalutamide to be administered either as monotherapy or in combination with androgen deprivation therapy (ADT) for adult men with high-risk biochemical recurrent (BCR) nmHSPC who are unsuitable for salvage-radiotherapy,” said president and CEO of Astellas, Naoki Okamura. “This approval is based on results from the phase 3 Embark trial ​ in 1,068 men with high-risk BCR nmHSPC,” Okamura continued. “The study demonstrated that patients treated with enzalutamide in combination with leuprolide had a 57.6% lower chance of cancer ​ spreading or death compared to those treated with leuprolide alone. Participants receiving enzalutamide alone experienced a 36.9% reduction in risk.” Prostate cancer can lead to metastasis Dr Antonio Alcaraz, chairman of the department of urology at the University Hospital Clinic of Barcelona said that when non-metastatic hormone-sensitive prostate cancer recurs and is allowed to evolve, it could potentially lead to metastasis. He said: “Facing a particularly high risk and poorer outcomes in this stage of prostate cancer are men with a rapidly rising PSA, where PSA levels double within 9 months. It is critical to manage the cancer carefully then, and I urge clinicians not to delay treatment in this setting.” Ernst-Günther Carl, chairman of Europa Uomo, expressed the urgent need for effective treatments for advanced prostate cancer. “Many men with hormone-sensitive prostate cancer undergo arduous surgery and rounds of radiotherapy, which can be a successful way to keep their cancer at bay,” he said. googletag.cmd.push(function () { googletag.display('text-ad1'); }); “It is devastating then when up to four in ten of those will go on to develop a recurrence that puts them at significantly greater risk of their cancer spreading and early death.” Potential new prostate cancer treatment Ahsan Arozullah, senior vice president and head of the oncology department at Astellas said this expanded approval is a vitally important advance for patients with nmHSPC with high-risk BCR. He said: “Efficacy and safety results from the Embark study demonstrate the potential for enzalutamide as a new option for treatment in the early, recurrent hormone-sensitive prostate cancer setting. Astellas is in active discussions with regulatory authorities around the world to bring enzalutamide to those who may benefit.” The EC's approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2024, recommending enzalutamide for high-risk BCR nmHSPC. Enzalutamide was previously approved by the US Food and Drug Administration (FDA) for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with BCR at high risk for metastasis in November 2023. Astellas ​ anticipates reflecting the impact of this approval in its financial forecast for the fiscal year ending March 31, 2025, scheduled for disclosure on April 25, 2024.