Please login to the form below

Not currently logged in
Email:
Password:

J&J files would-be prostate cancer blockbuster in US

Androgen receptor inhibitor achieves ‘significant’ MFS improvement over placebo

J&J

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.

Article by
Phil Taylor

12th October 2017

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Branding Science

We are Branding Science Partners in thinking which inspires change in healthcare Branding Science are an award-winning global pharmaceutical market...

Latest intelligence

The Patient Will See You Now – The Evolution of the Doctor-Patient Relationship
The doctor-patient relationship is an ever changing one that changes as society changes. Technology then helps to drive this change along with a wide number of other factors....
Mind the Gap – Challenging Immunisation Apathy and Misinformation
world, the biggest challenges remain apathy and misinformation. Since a measles vaccine was introduced in the UK in 1968, Public Health England estimates that 20 million measles cases and 4,500...
Towards Better HCP Engagement – An Email Masterclass
6% of HCPs prefer being contacted by email, compared to 17% who favour the second most popular option: direct interaction with reps....