Janssen’s Erleada is Reconsidered by NICE, Gaining a Positive Recommendation

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NICE has reconsidered its decision on Janssen's Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.

The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has reconsidered its decision on Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.

According to a Sept. 8, 2021 company press release, the FADs released by NICE are for the recommendation of apalutamide in combination with androgen deprivation therapy (ADT) as a treatment for prostate cancer in adult patients. NICE reported in a release on the same date, that the positive recommendations followed an improve discount on the price of the therapy offered by the company.

The therapy in combination with ADT is indicated for two treatment options within its marketing authorization: either as an option to treat hormone-sensitive metastatic prostate cancer (mHSPC) in adults when docetaxel is not suitable or cannot be treated; or as an option for treating hormone-relapsed non-metastatic prostate cancer (nmHRPC) that carries a high risk of metastasizing in adults.

“Despite significant advances in treatment options through research in advanced prostate cancer management, unfortunately in some patients the prognosis can be poor,” said Professor Amit Bahl, consultant clinical oncologist and uro-oncology research lead at Bristol Hematology & Oncology Centre, in the company press release. “The addition of apalutamide to the treatment pathway provides eligible prostate cancer patients with a therapy option with significant survival benefit as shown in clinical trials. It is a vital step towards improving outcomes in prostate cancer and enabling patients to have a better prognosis.”


“[The] positive recommendation for apalutamide marks a significant milestone in our mission to bring new therapeutic options to patients with mHSPC and nmHRPC,” added Sarah Scanlon, business unit director, Oncology, Hematology, and Pulmonary Hypertension, Janssen, in the press release. “We are delighted that NICE has given the green light for apalutamide for both indications and look forward to seeing these groups of patients benefit from a new treatment option.”

Sources: Janssen, NICE