Johnson & Johnson has filed for approval in the US for its prostate cancer drug apalutamide, one of ten new drug candidates that J&J thinks could eventually make sales of more than $1bn a year.
The drug is the first agent submitted to the FDA for use in patients with castration-resistant prostate cancer (CRPC) whose tumours are at risk of spreading (metastasising), but have not yet done so. At the moment there is no drug approved for patients in that category in the US.
Apalutamide is described as a next-generation oral androgen receptor inhibitor and has been filed based on the results of the SPARTAN trial, which compared the drug to placebo in non-metastatic CRPC patients who were experiencing rising levels of prostate-specific antigen, a biomarker that is linked to worsening disease.
The main outcome in the trial is metastasis-free survival (MFS), and while J&J’s Janssen drugs unit says its drug achieved a significant improvement over placebo on that measure, it isn’t giving away further details until it has the opportunity to present the data in full as a future medical meeting.
“The SPARTAN data lead the path towards a new approach to treating men with prostate cancer earlier in the disease course”, said Janssen’s head of oncology Peter Lebowitz. “We look forward to a promising treatment that can provide new hope and expectations for men facing this disease.”
J&J is also carrying out the ATLAS trial of apalutamide in combination with radiation therapy in men with high-risk localised and locally advanced prostate cancer, as well as phase III study of the drug alongside abiraterone acetate and prednisone in chemotherapy-naïve metastatic CRPC.
Analysts at Wells Fargo raised their rating for J&J just ahead of the filing, saying that its pipeline is ‘coming to fruition’ at a time when product sales are picking up and the threat of biosimilar competition to big-selling biologic drugs such as Remicade (infliximab) is becoming ‘more measured’. They also suggest that J&J’s recent acquisition of Actelion will help sales growth accelerate.
That view was echoed by Jefferies Jeffrey Holford, who says J&J’s so-called TIRADE products – Tremfya (guselkumab) for psoriasis, cancer drug Imbruvica (ibrutinib), anticoagulant rivaroxaban (Xarelto), apalutamide, Darzalex (daratumumab) for multiple myeloma, and antidepressant esketamine – will help drive strong earnings.
Along with apalutamide J&J is also intending to file its PARP inhibitor Zejula (niraparib), which is already approved for ovarian cancer as a treatment for advanced prostate cancer in men with specific tumour-associated mutations in the DNA repair anomaly group. The drug is currently in phase II testing for prostate cancer.